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

• ClinicalTrials.gov Identifier: NCT05371756
• Recruitment Status: Recruiting
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Sponsor: Baylor Research Institute
• Collaborator: Translational Genomics Research Institute
• Information provided by (Responsible Party): Baylor Research Institute

Study Description

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
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 Design

• 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

Groups and Cohorts

Outcome Measures

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 ]
   Immunohistochemistry
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.

Eligibility Criteria

• 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Sido Oghenevovwero, MS; 214-820-6168 ext 42-6168; corcsolidtumor@BSWHealth.org

Contact: Keisha Riser, MBA; 214-820-8165 ext 42-8165; keisha.riser@bswhealth.org

Locations

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

Investigators

• 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

More Information

• Responsible Party: Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT05371756
• Other Study ID Numbers: 019-350
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baylor Research Institute:

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