This study is not yet accepting patients

UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations

a study on Solid Tumor Somatic Mutation Hereditary Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Varun Monga, MBBS (ucsf)
Headshot of Varun Monga
Varun Monga

Description

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.

Official Title

UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations

Details

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.

Keywords

Solid Tumor, Solid Tumor, Adult, Somatic Mutation, Solid Tumor, Unspecified, Adult, Hereditary Cancer, Germline Mutations, Tumor-Associated Mutations, Blood Specimen Collection, Histocompatibility Testing, Medical Chart Review

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  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.

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Varun Monga, MBBS (ucsf)
    Dr. Varun Monga is a Board Certified Medical Oncologist who serves as an Clinical Associate Professor of Medicine in the Division of Hematology and Oncology. He joined UCSF Medical Center in 2023 and he provides patient care services limited to UCSF Sarcoma Center and Cancer Clinical Trials and Investigational Treatments Center.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06895681
Study Type
Observational [Patient Registry]
Participants
Expecting 50000 study participants
Last Updated