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RecruitingObservational

The Texas Immuno-Oncology Biorepository: Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers That Predict Benefit/Resistance to Cancer Therapeutics.

NCT ID: NCT05371756Sponsor: Baylor Research InstituteLast updated: 2026-03-16

Summary

The purpose of the Texas Immuno-Oncology Biorepository (TIOB) is to collect and store well-defined and well-annotated serial biospecimens of tissue, blood, urine and stool in a longitudinal manner from cancer patients who are receiving either standard of care surgical interventions and or FDA approved immunotherapeutics across the largest not-for-profit health system in Texas. Comprehensive clinical and radiological data from a diverse population of patients with different racial, social and ethnic backgrounds matched with serial biospecimens over a patients journey with cancer marks the TIOB as a unique research facility.

Detailed description

The goal of establishing the Texas Immuno-Oncology Biorepository (TIOB) is to create a research facility that purposely consents patients to collect, catalog, process, store, and analyze biospecimens with well-annotated clinical/radiological data from patients receiving surgical interventions or immunotherapeutics in our combined clinics throughout Texas. Potential types of studies that will be enabled by this resource will include but are not limited to (a) morphological studies including immunohistochemistry, (b) genomic and molecular analysis, including circulating, cell-free DNA, RNA, as well as extracellular vesicles and their cargo, (c) proteomic analysis involving protein isolation, (d) interrogation of circulating immune cells as well as the underlying tumor immune microenvironment, and (e) single-cell and spatial transcriptomics. Correlation of these studies with clinical, treatment outcome, and demographic information will be possible. Translation of multi-omics technologies will be a key feature of the TIOB and data integration strategies including genomics, epigenomics, transcriptomics, proteomics, radiomics, metabolomics and microbiomics will be possible and offer opportunities to improve our understanding of the complex biological interactions that define cancer.

Arms & interventions

Outcome measures

Primary

  • Develop a biorepository

    Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated patho-clinical data for development of new diagnostic and therapeutic technology.

    Time frame: 15 years

Secondary

  • Release of Specimens

    Time frame: 30 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Participant is over 18 years of age at the time of signing the informed consent form. * Participant is able and willing to sign an informed consent form. * Participant is suspected by a provider of being at risk for developing cancer, OR * Participant has confirmed or clinically suspected malignancy by a provider. This includes but is not limited to: 1. Participants who may be candidates for or are scheduled to receive standard of care immunotherapy treatment for the first time for their current cancer diagnosis, regardless of any prior non-immunotherapy treatment. 2. Participants who are enrolled in a clinical trial to receive an investigational, novel immunotherapy drug for the first time for their current cancer diagnosis. 3. Participants who may be surgical candidates for their current cancer diagnosis, regardless of any prior treatment. Exclusion Criteria: * Participant is unable or unwilling to donate blood. * Concurrent medical or psychiatric condition or disease that may compromise the ability to give documented informed consent, is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.

Study locations (8)

Baylor Scott & White Medical Center - College Station

College Station, Texas, 77845

Recruiting

Baylor University Medical Center - Dallas

Dallas, Texas, 75246

Recruiting
Pukar Ratti, MSChE, MSHCM · Contact
Ronan J Kelly, MD, MBA · Principal Investigator

Baylor Scott & White All Saints Medical Center - Fort Worth

Fort Worth, Texas, 76104

Recruiting
Pukar Ratti, MSChE, MSHCM · Contact

Baylor Scott & White Medical Center - Plano

Plano, Texas, 75093

Recruiting
Pukar Ratti, MSChE, MSHCM · Contact

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas, 78665

Recruiting

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508

Recruiting

Baylor Scott & White Medical Center - Hillcrest

Waco, Texas, 76712

Recruiting

Baylor Scott & White Medical Center - Waxahachie

Waxahachie, Texas, 75165

Recruiting
Pukar Ratti, MSChE, MSHCM · Contact

References

  • Yehuda Brody et al. Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA. ISLB 2025.
  • Yehonatan Elon et al. Longitudinal plasma proteomic analysis: A monitoring strategy for NSCLC patients treated with immunotherapy.. J Clin Oncol 43, 8579-8579(2025). DOI:10.1200/JCO.2025.43.16_suppl.8579
  • Kelly RJ, Whitsett TG, Snipes GJ, Dobin SM, Finholt J, Settele N, Priest EL, Youens K, Wallace LB, Schwartz G, Wong L, Henderson SM, Gowan AC, Fonkem E, Juarez MI, Murray CE, Wu J, Van Keuren-Jensen K, Pirrotte P, Highlander S, Contente T, Baker A, Victorino J, Berens ME. The Texas Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling. Proc (Bayl Univ Med Cent). 2022 Aug 26;36(1):1-7. doi: 10.1080/08998280.2022.2114129. eCollection 2023.(PubMed)