UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

NCT06895681 | Not Yet Recruiting

• 1 other identifier: 24986
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Germline Mutations; Tumor-Associated Mutations

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Procedure: Tissue Sample; Procedure: Excess fluid Sample; Other: Medical Chart Review

Interventions

Blood Sample PROCEDURE

Obtained at the time of non-study related routine blood draw.

Also known as: Blood Specimen

Adults with solid tumor malignancies

Tissue Sample PROCEDURE

Obtained at the time of non-study related routine biopsy or surgical procedure.

Also known as: Tissue Specimen

Adults with solid tumor malignancies

Excess fluid Sample PROCEDURE

Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.

Adults with solid tumor malignancies

Medical Chart Review OTHER

Demographic, clinical, and pathologic information will be extracted from the medical record

Also known as: Medical Record Review

Adults with solid tumor malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• For participants undergoing collection of tissue, ascites, and/or pleural effusions:
• Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
• Individuals 18 years of age or older on the day of signing informed consent.
• Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and/or Individuals with a family history or personal history of cancer.
• 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):
• Surgical resection
• Biopsy (open, incisional, excisional, punch, core needle, and/or fine needle aspiration (FNA) are all permitted)
• Paracentesis
• Thoracentesis
• For participants undergoing blood banking:
• Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
• Individuals 18 years of age or older on the day of signing informed consent.
• Individuals with a family history or personal history of cancer.
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participant-derived tissue, blood, ascites fluid, and pleural fluid samples will be collected

MeSH Terms

Interventions

Blood Specimen Collection; Histocompatibility Testing

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Study Officials

• Varun Monga, MBBS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phu Lam

CONTACT

877-827-3222; Phu.Lam@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)