UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor; Solid Tumor, Adult; Solid Tumor, Unspecified, Adult; Hereditary Cancer; Somatic Mutation
• Intervention / Treatment: Procedure: Blood Sample; Procedure: Tissue Sample; Procedure: Excess fluid Sample; Other: Medical Chart Review

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with solid tumor malignancies and germline or somatic mutations for cancer and/or a personal or family history of cancer

Description

Inclusion Criteria:

For participants undergoing collection of tissue, ascites, and/or pleural effusions:

1. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
2. Individuals 18 years of age or older on the day of signing informed consent.
3. Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and/or Individuals with a family history or personal history of cancer.

4. Must be planning to undergo one of the following procedures as part of their routine care (or as a research procedure under a UCSF-sponsored IIT protocol):

   1. Surgical resection
   2. Biopsy (open, incisional, excisional, punch, core needle, and/or fine needle aspiration (FNA) are all permitted)
   3. Paracentesis
   4. Thoracentesis

For participants undergoing blood banking:

1. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
2. Individuals 18 years of age or older on the day of signing informed consent.
3. Individuals with a family history or personal history of cancer.
4. Must be planning to undergo a blood draw as part of their routine care (or as a research procedure under a University of California, San Francisco (UCSF) -sponsored investigator-initiated trial (IIT) protocol); or willing to undergo an additional blood draw outside of their routine care.

Exclusion Criteria:

1. Known history of HIV, Hepatitis B, or Hepatitis C (as documented in the medical record) or other infectious disease that in the judgment of the investigator could pose a risk to research personnel or mice, or negatively impact Patient derived xenografts (PDX) tumor engraftment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adults with solid tumor malignancies; Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants.

Procedure: Blood Sample; Obtained at the time of non-study related routine blood draw.; Other Names: Blood Specimen; Procedure: Tissue Sample; Obtained at the time of non-study related routine biopsy or surgical procedure.; Other Names: Tissue Specimen; 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; Other Names: Medical Record Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop participant-derived tumor models of hereditary cancers	Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). These models recapitulate the biology and tissue context of the original tumors from which they are derived and can be used to study effective therapeutic strategies.	Up to 10 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Varun Monga, MBBS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Germline Mutations; Tumor-Associated Mutations
• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Immunologic Techniques; Immunologic Tests; Blood Specimen Collection; Histocompatibility Testing
• Other Study ID Numbers: 24986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No