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

NCT ID: NCT05371756

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2052-09-11

Brief 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.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Understand and willingness to sign written informed consent method.
• Patients who are suspected by a physician of being at risk for developing cancer.
• Patients with confirmed or clinically suspected malignancy by a physician. This includes but is not limited to candidates for immunotherapy, surgical candidates, patients receiving Standard of Care drugs, immunotherapy drugs, participating on a clinical trial with immunotherapy drugs, patients who have received immunotherapy drugs in the past, patients with any other approved or investigational disease management.

Exclusion Criteria

• Patients unwilling to donate blood
• Patients unwilling to provide informed consent for the collection of fresh or archived tumor tissue.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Translational Genomics Research Institute

OTHER

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronan J Kelly, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White Research Institute

Locations

Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pukar Ratti, MSChE, MSHCM

Role: CONTACT

TIOBReferral@BSWHealth.org

214-818-8472

Facility Contacts

Pukar Ratti, MSChE, MSHCM

Role: primary

TIOBReferral@BSWHealth.org

214-818-8472

References

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 36578607 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

019-350

Identifier Type: -

Identifier Source: org_study_id