Clinical trial NCT05371756: The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Biorepository
Immuno-Oncology
Molecular Biomarkers
Benefit & Resistance
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
First posted: 2022-05-12
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients due to receive or who have received immunotherapeutic drugs.

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.

Eligibility 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.

Primary outcomes:
measure: Develop a biorepository
timeFrame: 30 years
measure: Release of specimens
timeFrame: 30 years
Secondary outcomes:
measure: Laboratory Testing
timeFrame: 30 years
measure: Laboratory Testing
timeFrame: 30 years
measure: Laboratory Testing
timeFrame: 30 years
measure: Laboratory Testing
timeFrame: 30 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: Baylor Scott & White Research Institute
name: Ronan Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: