The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.

Official title

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

Overview

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.

Primary outcome measures

• Develop a biorepository [Time frame: 15 years]

Secondary outcome measures (1)

• Release of Specimens [Time frame: 30 years]

Eligibility criteria

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:

• 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.
• Participants who are enrolled in a clinical trial to receive an investigational, novel immunotherapy drug for the first time for their current cancer diagnosis.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 8 centers

• Baylor Scott & White Medical Center - College Station — College Station
• Baylor University Medical Center - Dallas — Dallas
• Baylor Scott & White All Saints Medical Center - Fort Worth — Fort Worth
• Baylor Scott & White Medical Center - Plano — Plano
• Baylor Scott & White Medical Center - Round Rock — Round Rock
• Baylor Scott & White Medical Center - Temple — Temple
• Baylor Scott & White Medical Center - Hillcrest — Waco
• Baylor Scott & White Medical Center - Waxahachie — Waxahachie

Publications

• 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 longitudi PMID 36578607

Identifiers

NCT: NCT05371756 · 019-350

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗