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

Cancer Clinical Trial

— TIOB  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371756
• Other study ID #: 019-350
• Status: Recruiting
• Start date: September 11, 2020
• Est. completion date: September 11, 2052

Study information

• Verified date: April 2022
• Source: Baylor Research Institute
• Contact: Sido Oghenevovwero, MS
• Phone: 214-820-6168
• Email: corcsolidtumor[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: September 11, 2052
• Est. primary completion date: September 11, 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Institute	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Translational Genomics Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Release of specimens	Implement release of specimens from biorepository for testing.	30 years
Secondary	Laboratory Testing	Immunohistochemistry	30 years
Secondary	Laboratory Testing	Genomic and Molecular analysis including circulating cell free DNA/RNA	30 years
Secondary	Laboratory Testing	Proteomic analysis	30 years
Secondary	Laboratory Testing	Single cell and Spatial transcriptomics	30 years