This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms (PanNEN). This protocol is an extension of existing Genetic Testing Station efforts at University of California, San Francisco (UCSF)
Histologically confirmed PanNEN.
New and existing PanNEN participants will be eligible (any grade, any stage, any age > 18 years).
Participants willing and able to comply with the study procedures.
Inability to provide informed consent.
Inability to speak/read a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic).
Active hematologic malignancy.
History of allogenic bone marrow transplant or stem cell transplant.
All participants receiving care at University of California participating locations with a new or existing diagnosis of PanNEN
Cohort
Prospective
Hereditary Cancer Panel
Diagnostic testUCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes
Rate of overall pathogenic germline mutations
The overall percentage of participants with pathogenic, or likely pathogenic germline mutations will be reported with 95% confidence intervals
Rates of different types of pathogenic mutations
The percentage of participants with each identified type of pathogenic, or likely pathogenic, will be reported with 95% confidence intervals
Rates of different types of variants of uncertain significance (VUS)
The percentage of participants with identified variants of uncertain significance will be reported with 95% confidence intervals.
Rate of declination for participants offered testing.
Participants who decline genetic testing but agree to participate in other study procedures will complete a Declination Survey which consists of one questions asking the reason for the decision to decline germline testing.
Rate of completion of testing
The rate of study completion defined as the percentage of participants who agree to testing, and complete all study procedures through return of results and meeting with genetic counselor (as appropriate) will be reported.
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University of California, San Francisco
Lead sponsor
University of California Pancreatic Cancer Consortium (UCPCC)
Collaborator
