UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

Primary Objective:

• 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

• To correlate in vivo drug sensitivity of participant-derived models with patient clinical response.
• To conduct blood-based assessment of tumor-associated biomarkers (DNA/RNA/protein, etc.).
• To describe tumor and blood-based biomarkers that are predictive of clinical response.
• To correlate changes in tumor and blood-based biomarker expression with clinical outcomes over time.
• To perform genomic and transcriptomic profiling of banked specimens and correlate findings with clinical outcomes, prognostic markers, and biomarkers.
• 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.

Inclusion criteria

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.

Exclusion criteria

• 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.