NCT06895681

UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary cancers and develop new efficient therapies.

Detailed description

Primary Objective: 1. To generate a repository of participant-derived tumor models\* and specimens\*\* - annotated with demographic, clinical, and pathologic data - from adults with solid tumor malignancies with germline or somatic tumor-associated mutations and/or a personal or family history of cancer. * Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). * Specimens may include tissue, ascites and pleural fluid, and blood. Exploratory Objectives 1. To correlate in vivo drug sensitivity of participant-derived models with patient clinical response. 2. To conduct blood-based assessment of tumor-associated biomarkers (DNA/RNA/protein, etc.). 3. To describe tumor and blood-based biomarkers that are predictive of clinical response. 4. To correlate changes in tumor and blood-based biomarker expression with clinical outcomes over time. 5. To perform genomic and transcriptomic profiling of banked specimens and correlate findings with clinical outcomes, prognostic markers, and biomarkers. 6. Unspecified cancer-centric research in the Munster Lab and other future unspecified research. OUTLINE: Participants will have biospecimens collected at non-study, routine procedures or visits to be stored at UCSF. Specimens will be processed and banked as per standard operating procedure. Participants will be followed through medical record chart review for a period of 10 years after signing informed consent, and be contacted every 3 months (± 2 months) for the first year and every 6 months (± 3 months) thereafter to allow updates to health status.

Conditions

• Solid Tumor
• Solid Tumor, Adult
• Somatic Mutation
• Solid Tumor, Unspecified, Adult
• Hereditary Cancer

Interventions

Type	Name	Description
PROCEDURE	Blood Sample	Obtained at the time of non-study related routine blood draw.
PROCEDURE	Tissue Sample	Obtained at the time of non-study related routine biopsy or surgical procedure.
PROCEDURE	Excess fluid Sample	Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.
OTHER	Medical Chart Review	Demographic, clinical, and pathologic information will be extracted from the medical record

Timeline

• Start date: 2026-01-31
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2025-03-26
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States