UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations
NCT ID: NCT06895681
Last Updated: 2025-11-10
Study Results
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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NOT_YET_RECRUITING
50000 participants
OBSERVATIONAL
2026-01-31
2035-12-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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CASE_CONTROL
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
Obtained at the time of non-study related routine blood draw.
Tissue Sample
Obtained at the time of non-study related routine biopsy or surgical procedure.
Excess fluid Sample
Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.
Medical Chart Review
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.
Tissue Sample
Obtained at the time of non-study related routine biopsy or surgical procedure.
Excess fluid Sample
Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.
Medical Chart Review
Demographic, clinical, and pathologic information will be extracted from the medical record
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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