The classic website will no longer be available as of June 25, 2024. Please use the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05371756
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : May 12, 2022
Translational Genomics Research Institute
Information provided by (Responsible Party):
Baylor Research Institute

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.

Condition or disease

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
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.
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : September 11, 2050
Estimated Study Completion Date : September 11, 2052

Primary Outcome Measures :
  1. Develop a biorepository [ Time Frame: 30 years ]
    Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and aligned clinical data for development of new diagnostic and therapeutic technology.

  2. Release of specimens [ Time Frame: 30 years ]
    Implement release of specimens from biorepository for testing.

Secondary Outcome Measures :
  1. Laboratory Testing [ Time Frame: 30 years ]

  2. Laboratory Testing [ Time Frame: 30 years ]
    Genomic and Molecular analysis including circulating cell free DNA/RNA

  3. Laboratory Testing [ Time Frame: 30 years ]
    Proteomic analysis

  4. Laboratory Testing [ Time Frame: 30 years ]
    Single cell and Spatial transcriptomics

Biospecimen Retention:   Samples With DNA
TIOB will collect tissue, bodily fluids, and blood samples.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients due to receive or who have received immunotherapeutic drugs.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05371756

Layout table for location contacts
Contact: Sido Oghenevovwero, MS 214-820-6168 ext 42-6168
Contact: Keisha Riser, MBA 214-820-8165 ext 42-8165

Layout table for location information
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Sido Oghenevovwero, MS         
Sponsors and Collaborators
Baylor Research Institute
Translational Genomics Research Institute
Layout table for investigator information
Principal Investigator: Ronan Kelly, MD Baylor Scott & White Research Institute
  Study Documents (Full-Text)

Documents provided by Baylor Research Institute:
Informed Consent Form  [PDF] September 16, 2021

Layout table for additonal information
Responsible Party: Baylor Research Institute Identifier: NCT05371756    
Other Study ID Numbers: 019-350
First Posted: May 12, 2022    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
Molecular Biomarkers
Benefit & Resistance