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

March 12, 2026 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77845
        • Recruiting
        • Baylor Scott & White Medical Center - College Station
        • Contact:
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center - Dallas
        • Contact:
        • Principal Investigator:
          • Ronan J Kelly, MD, MBA
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Baylor Scott & White All Saints Medical Center - Fort Worth
        • Contact:
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Medical Center - Plano
        • Contact:
      • Round Rock, Texas, United States, 78665
        • Recruiting
        • Baylor Scott & White Medical Center - Round Rock
        • Contact:
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center - Temple
        • Contact:
      • Waco, Texas, United States, 76712
        • Recruiting
        • Baylor Scott & White Medical Center - Hillcrest
        • Contact:
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • Baylor Scott & White Medical Center - Waxahachie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Surgical
Early stage, operable cancers
Immunotherapy
Metastatic, non-operable cancers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a biorepository
Time Frame: 15 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Release of Specimens
Time Frame: 30 years
Promote and implement release of specimens from biorepository for further research utilization including but 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.
30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Translational Genomics Research Institute

Investigators

  • Principal Investigator: Ronan J Kelly, MD, MBA, Baylor Scott & White Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Estimated)

September 11, 2035

Study Completion (Estimated)

September 11, 2050

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019-350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The study team is still evaluating this further.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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