UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

NCT ID: NCT06895681

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2035-12-31

Brief Summary

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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

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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

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

Keywords

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Germline Mutations Tumor-Associated Mutations

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood Sample

Intervention Type PROCEDURE

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

Tissue Sample

Intervention Type PROCEDURE

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

Excess fluid Sample

Intervention Type PROCEDURE

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

Medical Chart Review

Intervention Type OTHER

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

Interventions

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Blood Sample

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

Intervention Type PROCEDURE

Tissue Sample

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

Intervention Type PROCEDURE

Excess fluid Sample

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

Intervention Type PROCEDURE

Medical Chart Review

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

Intervention Type OTHER

Other Intervention Names

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Blood Specimen Tissue Specimen Medical Record Review

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Munster, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Phu Lam

Role: CONTACT

Phone: 877-827-3222

Email: [email protected]

Facility Contacts

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Phu Lam

Role: primary

Role: backup

Other Identifiers

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24986

Identifier Type: -

Identifier Source: org_study_id