Registry for BRCA Mutation Carriers with Pancreatic Ductal Adenocarcinoma
This study creates a registry for BRCA mutation carriers with pancreatic ductal adenocarcinoma. A registry is a database of information. A registry may help doctors to better understand why pancreatic cancer develops in some people who are known carriers of the gene mutation (an abnormality) called BRCA, or its close relative PALB2. This study aims to see why pancreatic cancer occurs in BRCA mutation carriers and whether or not there is a difference between pancreatic cancer among people of Ashkenazi Jewish descent who do and do not have BRCA mutations.
Inclusion Criteria
- BRCA mutation carrier is defined as a person with any mutation of the BRCA gene, including BRCA1, or BRCA2. PALB2mut patients are also eligible
- Relative of a BRCA PDAC patient is defined as a first-degree or second-degree relative, which includes parents, siblings, children, grandparents, grandchildren, aunts, uncles, nephews, nieces and half-siblings
- Participants in Control Cohort 5 are people of AJ descent who are first-degree or second degree relatives of an AJ descent non-BRCAmut patient with PDAC
- A Multiplex family is defined as one in which there are at least two first or second degree relatives with PDAC
- STUDY GROUP A: Known BRCA mutation carrier
- STUDY GROUP A: Ashkenazi Jewish descent (at least one parent of Ashkenazi Jewish origin)
- STUDY GROUP A: Histologic proof of primary pancreatic ductal adenocarcinoma
- STUDY GROUP A: May have either potentially curable (resectable) primary PDAC, localized but unresectable primary PDAC, or metastatic (stage IV) PDAC
- STUDY GROUP A: Prior personal history of other malignancy; either prior or currently active, including breast, ovarian, or prostate cancer is allowed
- STUDY GROUP A: Both previously treated and previously untreated patients are eligible. Previous treatment may include surgical resection, regional radiation therapy, or systemic therapy. Patient may be receiving active therapy
- STUDY GROUP A: Willing to provide blood specimens for correlative studies
- STUDY GROUP A: Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). New tumor biopsies are not required for entrance into the Registry
- STUDY GROUP B: Known BRCA mutation carrier
- STUDY GROUP B: Histologic proof of primary pancreatic ductal adenocarcinoma
- STUDY GROUP B: May have either potentially curable (resectable) primary PDAC, localized but unresectable primary PDAC, or metastatic (stage IV) PDAC
- STUDY GROUP B: Prior personal history of other malignancy; either prior or currently active, including breast, ovarian, or prostate cancer is allowed
- STUDY GROUP B: Both previously treated and previously untreated patients are eligible. Previous treatment may include surgical resection, regional radiation therapy, or systemic therapy. Patient may be receiving active therapy
- STUDY GROUP B: Willing to provide blood specimens for correlative studies
- STUDY GROUP B: Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). New tumor biopsies are not required for entrance into the Registry
- COHORT 1A: Known BRCA mutation carrier
- COHORT 1A: Ashkenazi Jewish descent (at least one parent of Ashkenazi Jewish origin)
- COHORT 1A: No current or prior history of PDAC
- COHORT 1A: First or second degree relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer
- COHORT 1A: Willing to provide blood specimens for correlative studies
- COHORT 1B: Known BRCA mutation carrier
- COHORT 1B: No current or prior history of PDAC
- COHORT 1B: First or second degree relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer
- COHORT 1B: Willing to provide blood specimens for correlative studies
- COHORT 2A: Known BRCA mutation carrier
- COHORT 2A: Ashkenazi Jewish descent (at least one parent of Ashkenazi Jewish origin)
- COHORT 2A: No current or prior history of PDAC
- COHORT 2A: First or second degree relative of a BRCAmut PDAC patient
- COHORT 2A: Prior or active personal history of any BRCA-related cancer
- COHORT 2A: Willing to provide blood specimens for correlative studies
- COHORT 2B: Known BRCA mutation carrier
- COHORT 2B: No current or prior history of PDAC
- COHORT 2B: First or second degree relative of a BRCAmut PDAC patient
- COHORT 2B: Prior or active personal history of any BRCA-related cancer
- COHORT 2B: Willing to provide blood specimens for correlative studies
- COHORT 3A: Known BRCAmut carrier
- COHORT 3A: Ashkenazi Jewish decent (at least one parent of Ashkenazi Jewish origin)
- COHORT 3A: No current or prior personal history of PDAC
- COHORT 3A: Prior personal history of other malignancy including breast, ovarian, or prostate cancer is allowed
- COHORT 3A: Willing to provide blood specimens for correlative studies
- COHORT 3B: Known BRCAmut carrier
- COHORT 3B: No current or prior personal history of PDAC
- COHORT 3B: Prior personal history of other malignancy including breast, ovarian, or prostate cancer is allowed
- COHORT 3B: Willing to provide blood specimens for correlative studies
- COHORT 4: Tested for and negative for the BRCA founder mutations
- COHORT 4: Ashkenazi Jewish descent (at least one parent of Ashkenazi Jewish origin)
- COHORT 4: Not related to known BRCAmut carrier
- COHORT 4: Histologic proof of primary pancreatic ductal adenocarcinoma. May have either potentially curable (resectable) primary PDAC, localized but unresectable primary PDAC, or metastatic (stage IV) PDAC
- COHORT 4: Both previously treated and previously untreated patients are eligible. Previous treatment may include surgical resection, regional radiation therapy, or systemic therapy. Patient may be receiving active therapy
- COHORT 4A: Willing to provide blood specimens for correlative studies
- COHORT 4: Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). New tumor biopsies are not required for entrance into the registry
- COHORT 5: Tested for and negative for the BRCA founder mutations
- COHORT 5: Ashkenazi Jewish decent (at least one parent of Ashkenazi Jewish origin)
- COHORT 5: No current or prior personal history of PDAC
- COHORT 5: Prior personal history of other malignancy including breast, ovarian, or prostate cancer is allowed
- COHORT 5: First or second degree relative of a Control-Cohort 4 participant from a multiplex PDAC family
- COHORT 5: Willing to provide blood specimens for correlative studies
Exclusion Criteria
- Are unable to sign informed consent for medical or other reasons
- Do not speak English (Memorial Sloan Kettering [MSK]) or do not speak English or Hebrew (BCGC Sites)
- Are under 21 years of age
- Not willing to provide blood samples for correlative studies
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01983410.
PRIMARY OBJECTIVE:
I. To establish a prospective registry of BRCA mutation carrier (BRCAmut) patients who have developed pancreatic ductal adenocarcinoma (PDAC), with appropriate controls.
SECONDARY OBJECTIVE:
I. To prospectively collect and store for current and future studies biological specimens from registry BRCAmut PDAC patients and appropriate controls including germline deoxyribonucleic acid (DNA), plasma, tumor tissue, and peripheral blood lymphocytes.
OUTLINE:
Patients complete questionnaires and undergo collection blood, tissue, and EBV immortalized lymphocytes samples. Patients' medical records are also reviewed. Patients may receive referral for genetic counseling.
Primary Study Group B non Ashkenazi Jewish descent BRCA mutation carriers with a personal history of pancreas cancer
Cohort 1B: Proven BRCA carrier 1st and second-degree relatives of Primary Study Group B without a personal history of a BRCA related cancer
Cohort 2B: Proven BRCA carrier 1st and second-degree relatives of Primary Study Group B with a personal history of a BRCA related cancer
Cohort 3B: Proven non Ashkenazi Jewish descent BRCA mutation carrier with family pedigree having no cases of BRCAmut pancreas cancer
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDavid Paul Kelsen
- Primary ID13-217
- Secondary IDsNCI-2021-11116
- ClinicalTrials.gov IDNCT01983410