Recruiting

Observational Study

Sponsor:

Baylor Research Institute

Code:

NCT05371756

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05371756

Start date

Sep 11, 2020

Status verified date

Mar, 2026

Completion date

Sep 11, 2050

Anticipated

Primary completion date

Sep 11, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical

Early stage, operable cancers

Immunotherapy

Metastatic, non-operable cancers

Primary outcome measure

  • Develop a biorepository [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

Locations

Baylor Scott & White Medical Center - College Station

Recruiting

College Station, Texas, United States, 77845

Contacts

Baylor University Medical Center - Dallas

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Ronan J Kelly, MD, MBA

Baylor Scott & White All Saints Medical Center - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Baylor Scott & White Medical Center - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Baylor Scott & White Medical Center - Round Rock

Recruiting

Round Rock, Texas, United States, 78665

Contacts

Baylor Scott & White Medical Center - Temple

Recruiting

Temple, Texas, United States, 76508

Contacts

Baylor Scott & White Medical Center - Hillcrest

Recruiting

Waco, Texas, United States, 76712

Contacts

Baylor Scott & White Medical Center - Waxahachie

Recruiting

Waxahachie, Texas, United States, 75165

Contacts

More Information

Sponsor

Baylor Research Institute

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-03-16.