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

NCT05371756 | Recruiting

• 1 other identifier: 019-350
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Cancer

Keywords

Biorepository; Immuno-Oncology; Molecular Biomarkers; Benefit & Resistance

Outcome Measures

Primary Outcomes (1)

• 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.

  15 years

Secondary Outcomes (1)

• Release of Specimens

  30 years

Study Arms (2)

Surgical

Early stage, operable cancers

Immunotherapy

Metastatic, non-operable cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected/confirmed cancers undergoing standard of care surgeries or with confirmed cancers receiving immunotherapeutic treatments.

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead
• Translational Genomics Research Institute: collaborator

Study Sites (8)

Baylor Scott & White Medical Center - College Station

College Station, Texas, 77845, United States

RECRUITING

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

RECRUITING

Baylor Scott & White All Saints Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor Scott & White Medical Center - Plano

Plano, Texas, 75093, United States

RECRUITING

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas, 78665, United States

RECRUITING

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

RECRUITING

Baylor Scott & White Medical Center - Hillcrest

Waco, Texas, 76712, United States

RECRUITING

Baylor Scott & White Medical Center - Waxahachie

Waxahachie, Texas, 75165, United States

RECRUITING

Related Publications (3)

• Yehuda Brody et al. Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA. ISLB 2025.

  RESULT

• 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

  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.

  PMID: 36578607 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, urine, saliva, and stool.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ronan J Kelly, MD, MBA

  Baylor Scott & White Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pukar Ratti, MSChE, MSHCM

CONTACT

214-818-8472; TIOBReferral@BSWHealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 12, 2022
• Study Start: September 11, 2020
• Primary Completion (Estimated): September 11, 2035
• Study Completion (Estimated): September 11, 2050
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (8)