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

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: Cancer

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 (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Sido Oghenevovwero, MS; Phone Number: 42-6168 214-820-6168; Email: corcsolidtumor@BSWHealth.org
• Study Contact Backup: Name: Keisha Riser, MBA; Phone Number: 42-8165 214-820-8165; Email: keisha.riser@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Research Institute
      • Contact: Sido Oghenevovwero, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients due to receive or who have received immunotherapeutic drugs.

Description

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.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop a biorepository	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.	30 years
Release of specimens	Implement release of specimens from biorepository for testing.	30 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory Testing	Immunohistochemistry	30 years
Laboratory Testing	Genomic and Molecular analysis including circulating cell free DNA/RNA	30 years
Laboratory Testing	Proteomic analysis	30 years
Laboratory Testing	Single cell and Spatial transcriptomics	30 years

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Translational Genomics Research Institute
• Investigators: Principal Investigator: Ronan Kelly, MD, Baylor Scott & White Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Anticipated): September 11, 2050
• Study Completion (Anticipated): September 11, 2052

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): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Biorepository; Immuno-Oncology; Molecular Biomarkers; Benefit & Resistance
• Other Study ID Numbers: 019-350

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No