UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

University of California San Francisco (UCSF)

Status: Not yet enrolling

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT06895681

24986

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50,000 participants in 1 patient group

Adults with solid tumor malignancies

Description:

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.

Treatment:

Procedure: Excess fluid Sample

Other: Medical Chart Review

Procedure: Blood Sample

Procedure: Tissue Sample