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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.
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).
Exploratory Objectives
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Procedure | Obtained at the time of non-study related routine blood draw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Develop participant-derived tumor models of hereditary cancers | 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. | Up to 10 years |
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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):
For participants undergoing blood banking:
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.
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Adults with solid tumor malignancies and germline or somatic mutations for cancer and/or a personal or family history of cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phu Lam | Contact | 877-827-3222 | Phu.Lam@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Varun Monga, MBBS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Participant-derived tissue, blood, ascites fluid, and pleural fluid samples will be collected
| Tissue Sample | Procedure | Obtained at the time of non-study related routine biopsy or surgical procedure. |
|
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| Excess fluid Sample | Procedure | Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure. |
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| Medical Chart Review | Other | Demographic, clinical, and pathologic information will be extracted from the medical record |
|
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |