Introduction
The Clinical Breast Care Project (CBCP) is a congressionally mandated program that combines clinical care and translational research across both military and civilian medical centers. Among active-duty servicewomen, breast cancer is the most common cancer-type with a higher incidence compared to civilians [Reference Lovejoy, Turner, Shriver and Ellsworth1,Reference Zhu, Devesa and Wu2]. The CBCP cohort allows for the study of breast cancer biology and outcomes within a population that has consistent access to screening and treatment services [Reference Pierre-Louis, Moore and Hamilton3].
CBCP currently operates across three clinical sites – Walter Reed National Military Medical Center (WRNMMC), Luminis Health Anne Arundel Medical Center (AAMC), and the Joyce Murtha Breast Care Center (JMBCC) – with research activities conducted at the Chan Soon-Shiong Institute of Molecular Medicine at Windber (CSSIMMW) and the Murtha Cancer Center Research Program of the Uniformed Services University of the Health Sciences/Henry Jackson Foundation. The program gathers longitudinal clinical data and biospecimens under IRB-approved protocols. Identifiable data remain secure at each collection site, while de-identified data and biospecimens are transferred to CSSIMMW for centralized processing, storage, and research use [Reference Shriver4].
Longitudinal research programs require systems that can capture and link clinical, demographic, and biospecimen data over time. Integrated data tracking systems have supported these efforts in settings such as clinical trials [Reference Curley, Evans, Kaylor, Pogash and Chinchilli5–Reference Sampson, Shapiro and He9], community health initiatives [Reference Wand, Crawford, Bell, Murphy, White and Wood10–Reference Kim, Cheney and Corbie-Smith13], research knowledge integration [Reference Payne, Ervin, Dhaval, Borlawsky and Lai14–Reference Anderson, Abend and Mandel17], and multi-institution data collection [18], providing improved data quality, accessibility, and operational efficiency [Reference Curley, Evans, Kaylor, Pogash and Chinchilli5–Reference Sinitkul, Maude and Nithirochananont8]. However, the commercial and open-source platforms available when the system was developed did not meet CBCP’s requirements for managing multi-visit and multi-institution workflows, securing military-network access, integrating pathology review, and maintaining a biospecimen chain-of-custody across clinical and research environments.
Therefore, we created the Data Tracking System for the Clinical Breast Care Project (DTS-CBCP), a secure, patient-centric, clinical-pathologic data and biospecimen management platform built to support long-term clinical-pathologic data collection, specimen procurement and tracking, and multi-site research activities. So far, CBCP has enrolled over 11,000 participants (Figure 1A) and manages over 100,000 biospecimens (Figure 1B), allowing for detailed annotation and follow-up across the military–civilian translational research network [Reference Shriver4].
CBCP (A) donor, and (B) specimen accrual plots. The CBCP program began consenting patients and accepting specimens in 2002 with an almost linear increase in specimen number ever since. CBCP = clinical breast care project.
DTS-CBCP was explicitly designed to meet these operational and security requirements and now serves as a foundation for future disease-specific systems in both military and civilian research settings. In this paper, we outline the architecture, development approach, and operational deployment of DTS-CBCP, demonstrating how it enables secure multi-institutional clinical and biospecimen workflows within an active military–civilian breast cancer research network.
Materials and methods
Design and architecture
DTS-CBCP was developed by the Informatics Infrastructure team at CSSIMMW to support secure, long-term management of breast cancer data and biospecimens across military and civilian clinical sites. System design priorities included consolidated capture of pathology, treatment, and outcome information; support for multi-site and multi-visit workflows; real-time patient and system activity monitoring; integrated clinical summary reporting; and secure access within and outside Department of Defense (DOD; recently renamed “Department of War,” DOW) networks [Reference Kvecher, Mostoller and Deyarmin19]. A user-centered approach guided the design, incorporating role-based access control and single sign-on authentication to ensure that clinical and research personnel could access only authorized tools and data elements.
A structured Case Report Form (CRF) was developed to collect de-identified clinical-pathologic, treatment, and outcome data, with each CRF component integrated into the system’s data model. The platform employs a web-based architecture compatible with standard web browsers, allowing controlled access from clinical and research environments. A detailed data dictionary guided metadata standards, ensuring consistent communication between clinical users and developers [Reference Kvecher, Mostoller and Deyarmin19]. Collected data are transferred to the Data Warehouse for Translational Research (DW4TR), where they are normalized to support custom data marts and downstream analytical workflows [Reference Hu, Correll and Kvecher20]. System audit logs record all user activities and data transactions to support regulatory compliance and operational oversight. DTS-CBCP was designed to enable controlled expansion while meeting DOD/DOW security requirements that prohibit the installation of unapproved software on networked systems.
Development methods
DTS-CBCP utilizes a patient-centric data model to integrate clinical encounters, pathology results, imaging, biospecimens, and associated data across multiple timepoints. This approach enables biospecimens and linked clinical information to support multiple studies, aligning data more closely with patient trajectories. In contrast, sample-centric systems concentrate on single events or limited follow-up. In this context, patient-centric refers to structuring data around participant’s longitudinal clinical histories and linked biospecimens, rather than direct participant involvement in system design or governance.
The system was developed using Agile methodology with iterative input from clinical, research, and informatics users from both military and civilian participating institutions to ensure usability and workflow alignment. No additional hardware is required at participating sites; the application is hosted on a Microsoft Windows Server environment running Internet Information Services (IIS), and the Informatics Infrastructure team at CSSIMMW manages server and application updates with minimal downtime.
A controlled software development lifecycle supports system reliability, security, and maintainability. Database schema updates are managed using Liquibase, with version-controlled scripts stored in a Git repository. Development and quality assurance workflows incorporate Docker-based environments, automated testing with Playwright, peer-reviewed QA environments, and a Jira-based system for change control and feature tracking. After QA validation, updates are deployed to a staging environment for final testing and then released to production.
The system employs a layered Model-View-Controller (MVC) architecture to separate presentation, application logic, and data access. The front-end is implemented using HTML, CSS, and JavaScript, while C# and ASP.NET MVC handle application logic. Back-end operations are supported by Oracle PL/SQL, with data access managed through stored procedures, Language Integrated Query (LINQ), and Entity Framework. This layered architecture enhances maintainability, scalability, and secure performance.
Results
System deployment and use
DTS-CBCP has been successfully implemented at both military and civilian clinical sites involved in the CBCP. The system facilitates participant registration, consent management, and structured data collection for clinical visits, pathology events, and the collection of biospecimens. Data entry is performed by trained data abstractors and clinical staff, with role-based access controls in place to ensure that proper permissions are granted.
Each participant’s visit results in a CRF, and pathology events are grouped into clinically relevant episodes (e.g., initial diagnosis, recurrence). Biospecimens are assigned unique barcodes, enabling multiple samples to be linked to a single individual across different time points. The system supports both manual and semi-automated data entry workflows, and its responsive web architecture provides controlled access from desktops and mobile devices at authorized sites.
As of November 6, 2025, DTS-CBCP has supported the registration of 11,452 participants, completion of over 22,000 CRFs, and tracking of 104,671 biospecimens across three clinical sites, with 99% system uptime since its implementation. The platform remains actively used on a daily basis to support ongoing research and biobank activities.
Modules and functional capabilities
DTS-CBCP includes integrated modules that support participant enrollment, biospecimen tracking, clinical data capture, and secure system administration (Figure 2). Core functional components include Security/Administration, Participant Management, CRFs, and Sample Tracking.
DTS-CBCP data model. After a participant is registered and assigned a protocol, patient data – including clinical information, treatment details, outcomes, and pathology – as well as biospecimen data are collected and entered into the system. This data can also be exported to the data warehouse, Freezerworks, and/or aperio for image analysis. DTS = data tracking system, CBCP = Clinical Breast Care Project, CRF = case report form, DW = data warehouse, DW4TR = data warehouse for translational research, FW = freezerworks.
Security and administration
DTS-CBCP uses role-based access control with 22 different security roles to provide varying permissions for military and civilian user groups. User authentication is handled through secure login and single sign-on methods, with automatic account lockout after failed login attempts or extended inactivity. Hosted within the CSSIMMW infrastructure, the system operates behind enterprise firewalls and endpoint security, with daily backups and intrusion detection. Audit logs record all user and data activity to ensure regulatory compliance. Application updates are tested system-wide before deployment, and the production environment is accessed via HTTPS, removing the need for local client installation. This centralized deployment approach ensures controlled release cycles and maintains a consistent security posture across locations.
Participant management
The Participant module allows authorized users to register new participants and view existing records using the CBCP identifier which is named as CBCP Number in the study (Figure 3A–3D). Participants provide informed consent before joining CBCP, with protocol details explained beforehand. Consent status, protocol assignment, and demographic details are recorded at enrollment. Optional cohort tagging enables connection to specific research efforts. This setup supports long-term follow-up and helps identify biospecimens and related data used in particular studies. DTS-CBCP is not used as a participant return-of-results platform. Participants are informed that research findings generated through CBCP are experimental, and will not be returned to participants or incorporated into clinical decision-making.
Screenshots from DTS-CBCP. (A) Home page; (B) Dashboard; (C) Participant page; and (D) Sample Master List. APOLLO = Applied Proteogenomic Oorganizational Learning and Outcomes program, DTS = data tracking system, CBCP = Clinical Breast Care Project, OCT = optimal cutting temperature compound, ORIEN = Oncology Research Information Exchange Network, QA = quality assurance, QC’ed = quality control review completed.
Figure 3. Long description
Panel A: The home page of the DTS-CBCP system with a welcome message and navigation menu. Panel B: The dashboard page displaying protocols, cohorts, and outcomes for a participant. The protocols section includes columns for protocol, status, consent date, and end date. The cohorts section shows cohort and enrollment date. The outcomes section lists record accessed, description, record status, QCed, pathologic category, status, status date, and actions. Panel C: The participant page with fields for editing participant information including CBCP number, site, date of birth, and program affiliations. Panel D: The sample master list page showing registered blood samples with columns for bar code, parent, Best block (BES), Path group ID (PATH), sample, match, blood, sample date, status, tissue, laterality, and weight. Each row lists specific sample details.
Based on IRB protocols, there are three main withdrawal scenarios: Withdrawal Scenario 1) a participant voluntarily withdraws consent from a study. The participant is provided the following two options: A) no new samples will be collected, but previously collected samples will remain in the CBCP repository, and data abstractor will continue to consult medical records to update the CRF and follow participant’s medical status, or B) previously collected samples will be destroyed, and the collection of CRF data and medical status information from participant’s medical records will cease. Under either option, any information already collected or data already generated (including molecular data) may continue to be used to ensure the scientific validity of the research. Withdrawal Scenario 2) if participant meets protocol-defined discontinuation criteria; and Withdrawal Scenario 3) if participant was enrolled or consented but was later determined not to meet study inclusion and/or exclusion criteria, generally occur when continuation in the study may be harmful or dangerous to the participant.
The participant’s status in DTS is also updated. The system displays a withdrawal notification page that includes accompanying withdrawal details. DTS users without security permissions are restricted from access beyond the withdrawal notification page. Authorized users, with appropriate security permissions, may proceed to participant’s record for operational, regulatory, or audit purposes. All participant-related pages display a visible banner indicating the participant’s withdrawn status.
When required, participant information is removed, updated, or clearly marked from supporting records and tracking documents to reflect the participant’s withdrawn status. Removal or modification of participant information is performed in accordance with institutional policies, regulatory requirements, sponsor instructions, and any applicable records retention requirements. All actions taken are documented.
Case report forms (CRFs)
CRFs collect structured data on clinical, treatment, outcomes, and pathology across multiple domains.:
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• Demographics & lifestyle factors
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• Reproductive history and non-cancer medical history
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• Family cancer history
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• Non-breast malignancies
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• Breast cancer-specific clinical and pathologic features
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• Treatment and outcome information
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• Prognostic studies and genetic testing
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• Pathology event grouping and biomarker results
Each CRF submission is checked through automated format validation and manual expert review to ensure accuracy and completeness. Supporting documents, including pathology reports, can be uploaded to connect clinical interpretation with biospecimen data.
Biospecimen tracking
Sample registration. The Sample module logs tissue and blood biospecimens collected during clinical encounters. Each biospecimen is assigned a unique barcode, and detailed metadata, including collection time, processing times, preservation method (FFPE, OCT, or frozen), and quantity, are recorded (Figure 4A–4E). The system maintains a complete record of sample status changes, including instances where biospecimens are exhausted or no longer available for research use.
Screenshots of available options from the Sample Master List. (A) Register Blood Sample; (B) Register Blood Samples; (C) Register Tissue Sample; (D) Sample Status; (E) Samples not available; (F) Ship samples; (G) Receive shipment; (H) Samples ready for archiving in Freezerworks; (I) Shipments archived in Freezerworks. AAMC = Anne Arundel Medical Center, APOLLO = Applied Proteogenomic Oorganizational Learning and Outcomes program, DTS = data tracking system, CBCP = Clinical Breast Care Project, DCIS = ductal carcinoma in situ, FW = freezerworks, g = grams, Img = image, mL = milliliter, OCT = optimal cutting temperature compound, ORIEN = Oncology Research Information Exchange Network, QA = quality assurance, WRI = Windber Research Institute, legal name of the organization now d.b.a. CSSIMMW; WRNMMC = Walter Reed National Memorial Medical Center.
Sample shipment and receipt. DTS-CBCP automatically produces shipping manifests and receipt documentation in PDF format. Shipment records include origin, destination, tracking numbers, batch identifiers, and receipt verification (Figure 4F–4G). Biospecimens stored in Freezerworks are traceable through integrated identifiers that ensure continuity across systems (Figure 4H–4I).
Verification and quality assurance. Verification workflows allow for real-time or delayed QC review by designated users or through batch audit reports. Data consistency checks and integrity rules are applied at both the field and record levels, supported by expert review. Randomized quarterly audits are carried out across biospecimens to monitor and verify data quality [Reference Zhang, Kvecher and Sun21].
Integration
DTS-CBCP integrates with institutional and third-party systems to facilitate smooth biospecimen management and digital pathology review. The platform sends curated clinical and biospecimen data to the Data Warehouse for Translational Research (DW4TR), where the information is normalized and accessible for queries, cohort identification, and downstream analysis. This integration eliminates duplicate data entry and enables investigators to access unified datasets, thereby supporting the advancement of translational research.
The system connects with Freezerworks [22] for biobank inventory management, updating biospecimen identifiers and availability status to ensure traceability across storage and research processes. This connection enables real-time updates of aliquot dispositions and freezer locations, ensuring that biospecimen availability accurately reflects operational biobank activities.
Pathology modules are integrated with Aperio ImageScope [23], enabling digital slide review and annotation within a secure system. Communication with the Aperio system happens through automated XML-based exchanges, and slide identifiers are stored in DTS-CBCP to connect histologic data and annotations with the relevant clinical and biospecimen records. Pathology images and metadata are stored in a secure repository, enabling authorized users to review digital slides remotely for diagnostic confirmation, quality assurance, and research annotation purposes.
As of August 1, 2025, the system has supported linking 29,000 digital slides, 17,300 annotated pathology events, and >219,000 Freezerworks-tracked aliquots, providing a unified view of clinical, pathology, and biobank data across three participating clinical sites. This integrated architecture facilitates tissue-based translational research and can be expanded to include additional diseases and research programs.
Reporting and data access
DTS-CBCP offers comprehensive reporting features to support clinical operations, biospecimen management, quality control, and research oversight. Built-in reports enable authorized users to view case enrollment, biospecimen availability, pathology events, and follow-up status across participating sites. Reports can be generated at the participant, visit, biospecimen, and program levels, facilitating real-time monitoring and ensuring regulatory compliance.
Statistical and summary reports monitor participant consent activity, biospecimen collection, pathology classifications, and blood and tissue processing across sites (Table 1). Continuing review reports support protocol oversight, including withdrawals, follow-up compliance, and tracking of adverse events. Biobank-specific reports oversee biospecimen receipt, processing workflow, and archival activity, providing visibility into freezer inventory and sample disposition. Audit reports track barcode activity, system access, and data modifications to support validation and compliance within a regulated environment.
Data Tracking System – Clinical Breast Care Project (DTS-CBCP) reports
Table 1. Long description
The table is organized into several categories: Statistical reports, Cumulative/quarterly/annual reports, Continuing review reports, and Biobank reports. Each category lists specific reports with descriptions. Statistical reports include Summary reports, Consent summary report, Consent site summary report, Consent collection summary report, Blood summary report, Tissue summary report, and Sample summary report. Cumulative/quarterly/annual reports provide summary information over different time periods. Continuing review reports include Protocol consents by site report, Participant consents by site report, Withdrawal detail report, Site pathology status report, Blood processing per month report, and Outcomes due reports. Biobank reports include Biobank receiving summary report, Sample reports, Sample activity and audit reports, and Histological annotation and audit reports. Each report type is described in terms of the information it provides, such as counts, types, and statuses of various activities and specimens.
Frequently used reports include participant consent summaries, outcomes-due reports, and biobank archival activity visualizations (Figure 5). These tools help clinical research and biobank teams monitor operational performance, identify participants due for follow-up, and evaluate biospecimen utilization. Ad hoc reports can be requested through the Informatics Infrastructure team, enabling investigators to customize cohort queries and data extracts for specific project needs.
Screenshots of the most commonly viewed reports in 2023. (Top row) Participant Consents by Site Report; (Middle row) Outcomes Due Report; (Bottom row) JMBCC Archived Samples Report. AAMC = Anne Arundel Medical Center, DTS = data tracking system, CBCP = Clinical Breast Care Project, ORIEN = Oncology Research Information Exchange Network, JMBCC = Joyce Murtha Breast Care Center, M0 = negative metastatic status, MX = metastatic status unknown, N0 = lymph node (-), N1a = lymph node (+), N0(i+) = lymph node isolated tumor cells only, (NED) = no evidence of disease, WRNMMC = Walter Reed National Memorial Medical Center. Tis = tumor size not invasive, T1c, T1, T2 = tumor sizes.
Figure 5. Long description
The image contains four screenshots of reports from a data tracking system. Panel A shows the Participant Consents by Site Report with fields for start and end dates, and a table displaying site codes, site names, and consent counts. Panel B displays the Participant Consents by Site Results for the period 01/01/2024 - 05/22/2024, including columns for site code, site name, new consents, reconsents, and total consents. Panel C shows the Outcomes Due Report with fields for site, month, year, and pathologic categories, and a table listing CBCP numbers, path categories, highest stages, races, cohorts, protocols, consent dates, germline blood, EDTA plasma, heparin plasma, frozen plasma, frozen tissue, FFPE, collection date, outcome date, vital status, and last to follow up. Panel D displays the JMBCC Archived Samples Report with fields for start and end dates, and a table showing sample ID, aliquot barcode, sample description, sample sub-type, sample date, arrival date, container type, hemolysis grading, origin, tissue bank, and archival date.
As of November 1, 2025, the reporting system has generated ∼200 ad hoc investigator reports/year, thereby improving oversight, reducing manual query workload, and enhancing translational research workflows across the network.
Use and impact
DTS-CBCP actively supports clinical operations and translational research within the CBCP network. The system enables the ongoing collection of clinical events, pathology findings, and biospecimen data, allowing investigators to identify cohorts, monitor patient outcomes, and request biospecimens for further studies.
Since deployment, DTS-CBCP has supported 11,452 participant enrollments, 10,500 longitudinal follow-up visits, and the tracking and management of 104,671 biospecimens across three military and civilian clinical sites. The platform facilitates investigator queries, biospecimen requests, and research projects. Since 2002, DTS-CBCP has supported approximately 90 research projects utilizing ∼40,000 biospecimens. CBCP specimens have been used in studies such as a therapy-relevant breast cancer stratification study funded by a Komen Promise grant [Reference Peck, Girondo and Liu24–Reference Chervoneva, Peck and Sun26], Applied Proteogenomic Organizational Learning and Outcomes (APOLLO) (APOLLO 4C-Breast Cancer and APOLLO 5-PanCancer) [Reference Raj-Kumar, Liu and Soltis27], Massive Parallel Molecular Processing of Breast Cancer (MPMP) [Reference Raj-Kumar, Lin and Liu28], Project for Military Exposures and Toxin History Evaluation in US service members (PROMETHEUS), The Cancer Genome Atlas (TCGA) [29–Reference Liu, Lichtenberg and Hoadley31], Clinical Proteomic Tumor Analysis Consortium (CPTAC) [Reference Mertins, Mani and Ruggles32], and other internal projects focused on breast cancer and tumor microenvironment analyses.
The system has contributed to improved operational efficiency through automated follow-up reminders, integrated inventory tracking, and centralized reporting dashboards, reducing manual data abstraction workloads and accelerating cohort identification workflows. These capabilities have enabled the distribution of biospecimens to internal and external investigators, contributing to peer-reviewed publications and presentations that have arisen from CBCP research efforts.
DTS-CBCP continues to serve as the centralized informatics backbone for CBCP, enabling secure, compliant, and scalable data and biospecimen management, and providing a foundation for multi-institutional breast cancer research in both military and civilian populations.
Discussion
This work describes the design and implementation of DTS-CBCP, a patient-centric data tracking system developed to support the CBCP. This translational research program encompasses the collection of long-term biospecimen and clinical data. Although DTS-CBCP was originally developed during early phases of CBCP, the present report describes the mature platform after more than a decade of operational use, expansion, integration, and refinement across multiple military and civilian institutions. The platform enables the standardized collection and integration of clinical, pathological, and biospecimen information, facilitating thorough follow-up and translational research workflows [Reference Peck, Girondo and Liu24–Reference Chervoneva, Peck and Sun26, Reference Somiari, Sullivan and Russell33–Reference Ru, Liu and Fantacone-Campbell37]. By supporting data entry at both collection and processing points, and linking biospecimen events to patient timelines, DTS-CBCP provides a unified environment for the secure, long-term management of breast cancer data.
DTS-CBCP improves and expands the capabilities of existing biospecimen and clinical data systems [Reference Arab, Hahn, Henry, Chacko, Winter and Cambou7,Reference Sinitkul, Maude and Nithirochananont8,Reference Wiley, Shortt and Roberts38]. Common platforms, such as caTissue and OpenSpecimen [Reference McIntosh, Sharma and Mulvihill39], LabVantage [40], and REDCap [18], support biospecimen management or clinical data collection, but are not designed to unify multisite biospecimen workflows, pathology review, and long-term clinical outcomes within a single, secure system. Unlike traditional sample-centric laboratory information management systems, DTS-CBCP uses a patient-centric architecture that coordinates clinical events and biospecimen activity over time. Integration with DW4TR [Reference Hu, Correll and Kvecher20], Freezerworks [22], and Aperio ImageScope [23] enables federated linkage of clinical, molecular, inventory, and digital pathology data while maintaining strict access controls.
The system was designed to meet strict regulatory and operational requirements for a hybrid military–civilian translational research network, including secure operation across the DOD/DOW and civilian settings while maintaining Health Insurance Potability and Accountability Act (HIPAA) compliance. Role-based access, audit logging, and layered security measures support regulated research activities. These features, along with user-friendly data entry interfaces and cross-platform reporting, contribute to DTS-CBCP’s utility in its ability to function across both restricted and open networks, as well as to support multi-institutional translational workflows. While the scientific objectives were consistent across participating sites, implementation required accommodation of different operational environments. Implementation occurred at all participating sites during the same general time period. Military sites imposed additional network and cybersecurity requirements, whereas civilian sites operated under different institutional processes. Harmonization of site-specific workflows and regulatory requirements was therefore an important consideration during deployment and ongoing system maintenance. Conversely, some patient follow-up processes were easier due to existing military healthcare medical record systems. Additionally, since each site had its own IRB requirements, coordinating site-specific regulatory and operational workflows required careful planning.
However, several limitations remain as mandated by the current practices in this research program; these include – manual extraction from electronic health records and partial automation of quality-control processes, which present opportunities for further improvement as the program evolves. Validated deployment within DOD/DOW infrastructure currently relies on Oracle and Microsoft systems, which may restrict portability. Going forward, efforts will focus on increasing the automation of data ingestion, developing intelligent quality-control agents, and expanding interoperability modules to enable broader integration with external clinical and research systems. Advanced analytical tools – such as data retrieval, automated monitoring workflows, and decision-support capabilities – may further enhance system performance as regulatory-compliant implementations evolve.
DTS-CBCP is a scalable purpose-built model or framework, for secure, patient-centric informatics that supports multi-institutional biospecimen-linked research in a regulated environment. By enabling longitudinal breast cancer cohort tracking and cross-system data integration, the platform creates a scalable, flexible model for future disease-focused and federated translational research systems, whose structure can be used as a framework for new studies after adaptation.
Conclusions
DTS-CBCP was developed to meet the operational and regulatory requirements of a multi-institutional military–civilian translational research program, ensuring the secure and consistent long-term tracking of clinical data and biospecimens. By combining patient-centric data collection, biospecimen management, and digital pathology review within a unified informatics platform, the system allows for ongoing follow-up, efficient cohort identification, and dependable linkage between biospecimens and clinical outcomes.
The system architecture demonstrates that a purpose-built platform can securely operate across DOD/DOW and civilian networks, while ensuring HIPAA compliance and supporting coordinated biospecimen-linked research across geographically dispersed centers. Future possible improvements include enhanced interoperability with external data sources, increased automation in ingestion and quality control processes, and the addition of regulated analytical support capabilities to streamline study execution.
DTS-CBCP offers a validated model for disease-focused, federated data and biospecimen systems within regulated environments. By supporting ongoing clinical cohort monitoring and cross-system data integration, the system facilitates biomarker-driven studies and long-term translational research initiatives.
Acknowledgments
Adam Stahl provided details on security. Ben Melikant contributed information about passwords, accounts, images, and proofreading. Bryant Onkst offered descriptions of Freezerworks. Boyi Chen reviewed the paper and gave feedback. Mitchell Johnson provided specimen statistics. We thank all patients who participated in the study. Portions of this manuscript were edited/refined using an AI-assisted tool (Grammarly v. 1.2.231.1817 (https://www.grammarly.com)). No AI-generated content was used without verification. All data interpretation and conclusions are original to the authors.
Author contributions
Bradley J. Mostoller: Conceptualization, Methodology, Software, Visualization, Writing - review & editing; Leonid Kvecher: Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Software, Supervision, Validation, Visualization; Rick M. Jordan: Writing - original draft, Writing - review & editing; Alex Seagal: Writing - original draft, Writing - review & editing; Brenda Deyarmin: Data curation, Investigation, Resources, Validation; J. Leigh Campbell: Data curation, Investigation, Resources, Validation; Jeffrey A. Hooke: Conceptualization, Investigation, Methodology, Project administration, Resources; Albert J. Kovatich: Investigation, Methodology, Resources; Kimberly N. Murtha: Conceptualization, Methodology, Software, Visualization; Frank Cammarata: Conceptualization, Methodology, Software, Visualization; Caroline Larson: Data curation, Resources, Validation; Stella Somiari: Data curation, Supervision; Simon Cocklin: Writing - original draft, Writing - review & editing; Xiaoying Lin: Writing - review & editing; Craig D. Shriver: Funding acquisition, Project administration, Supervision; Hai Hu: Funding acquisition, Project administration, Supervision, Writing - review & editing.
Funding statement
This work was supported by the Clinical Breast Care Project, funded by the U.S. Department of War (previously Department of Defense) through the Henry Jackson Foundation for the Advancement of Military Medicine: W81XWH-12-2-0050/2350, HU0001-16-2-0004, HU0001-19-20058/5171, HU0001-23-20022, HU0001-24-20049.
Competing interests
The authors declare no competing interests or personal relationships that influenced the work reported in this manuscript. Hai Hu is co-founder and shareholder of miRoncol Diagnostics, Inc. (not related to the reported work). Simon Cocklin is co-founder and shareholder of Bespoke Patient Solutions, LLC. (not related to the reported work).
Disclaimer
The contents of this publication are solely the responsibility of the author(s) and do not necessarily reflect the views, opinions, or policies of the Uniformed Services University of the Health Sciences (USUHS), the Henry M. Jackson Foundation (HJF) for the Advancement of Military Medicine, Inc., the Department of Defense/Department of War (DOD/DOW), or the Departments of the Army, Navy, or Air Force. Mention of trade names, commercial products, or organizations does not imply endorsement by the U.S. government.
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