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

ConditionCancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBaylor Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

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.

Disqualifiers

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.

Trial population

Patients with suspected/confirmed cancers undergoing standard of care surgeries or with confirmed cancers receiving immunotherapeutic treatments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants

are grouped into 2 trial groups

Group A: Surgical

Group B: Immunotherapy

Trial outcomes

Primary outcomes

Develop a biorepository

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.

Time frame

15 years

Secondary outcomes

Release of Specimens

Promote and implement release of specimens from biorepository for further research utilization including but 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.

Time frame

30 years

Locations8

Select a site below to view it on the map.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor Research Institute

Lead sponsor

Translational Genomics Research Institute

Collaborator

Source ClinicalTrials.gov

Apply now