Hereditary Cancer, Solid Tumor, Solid Tumor, Adult, Solid Tumor, Unspecified, Adult, Somatic Mutation
Conditions
Keywords
Germline Mutations, Tumor-Associated Mutations
Brief 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.
Detailed 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.
Interventions
PROCEDUREBlood Sample
Obtained at the time of non-study related routine blood draw.
PROCEDURETissue Sample
Obtained at the time of non-study related routine biopsy or surgical procedure.
PROCEDUREExcess fluid Sample
Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.
OTHERMedical Chart Review
Demographic, clinical, and pathologic information will be extracted from the medical record
Sponsors
University of California, San Francisco
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Develop participant-derived tumor models of hereditary cancers | Up to 10 years | Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). These models recapitulate the biology and tissue context of the original tumors from which they are derived and can be used to study effective therapeutic strategies. |
Contacts
PRINCIPAL_INVESTIGATORVarun Monga, MBBS
University of California, San Francisco
Outcome results
None listed