The Texas Immuno-Oncology Biorepository: Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers That Predict Benefit/Resistance to Cancer Therapeutics.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 10,000
- Locations
- 9
- Primary Endpoint
- Develop a biorepository
Study Overview
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.
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
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •Participant has confirmed or clinically suspected malignancy by a provider. This includes but is not limited to:
- •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.
- •Participants who are enrolled in a clinical trial to receive an investigational, novel immunotherapy drug for the first time for their current cancer diagnosis.
- •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.
Arms & Interventions
Surgical
Early stage, operable cancers
Immunotherapy
Metastatic, non-operable cancers
Outcomes
Primary Outcomes
Develop a biorepository
Time Frame: 15 years
Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated patho-clinical data for development of new diagnostic and therapeutic technology.
Secondary Outcomes
- Release of Specimens(30 years)