A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is 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. The investigators hope to do this by establishing a BRCA/PALB2 mutation carriers Pancreatic Ductal Adenocarcinoma (the common form of pancreatic cancer) Registry. A registry is a database of information.

Official Title
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A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Behavioral: The risk assessment questionnaire
* Other: Blood specimens
* Other: tumor tissue samples will be requested


Participation Criteria
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Eligibility Criteria
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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 relative, which includes, parents, siblings or children. BRCAmut PDAC Group: Study Group A: Ashkenazi Jewish descent Known BRCA mutation carrier. Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin). 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. Prior personal history of other malignancy; either prior or currently active, including breast , ovarian or prostate cancer is allowed. 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. Willing to provide blood specimens for correlative studies. 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. BRCAmut PDAC Group: Study Group B: non-Ashkenazi Jewish descent Know n BRCA mutation carrier. 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. Prior personal history of other malignancy; either prior or currently active, including breast, ovarian, or prostate cancer is allowed. 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. Willing to provide blood specimens for correlative studies. 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. BRCA mutation carrier, relative of a BRCA PDAC patients, without PDAC or other BRCAmut related malignancy: (Control Cohort 1A): Ashkenazi Jewish descent Known BRCA mutation carrier. Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin). No current or prior history of PDAC. Relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer Willing to provide blood specimens for correlative studies. BRCA mutation carrier, relative of a BRCA PDAC patients, without PDAC or other BRCAmut related malignancy: (Control Cohort 1B): non-Ashkenazi Jewish descent Know n BRCA mutation carrier. No current or prior history of PDAC. First or second degree relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer. Willing to provide blood specimens for correlative studies. BRCAmut Carrier relative of a BRCAmut PDAC patient who themselves have prior or active BRCAmut related malignancy (Control Cohort 2A):Ashkenazi Jewish descent Known BRCA mutation carrier. Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin). No current or prior history of PDAC. Relative of a BRCAmut PDAC patient. Prior or active personal history of any BRCA-related cancer. Willing to provide blood specimens for correlative studies. BRCAmut Carrier relative of a BRCAmut PDAC patient who themselves have prior or active BRCAmut related malignancy (Control Cohort 2B): non-Ashkenazi Jewish descent Know n BRCA mutation carrier. No current or prior history of PDAC. First or second degree relative of a BRCAmut PDAC patient. Prior or active personal history of any BRCA-related cancer. Willing to provide blood specimens for correlative studies. BRCAmut carrier who is not related to a BRCAmut PDAC patient: (Control cohort 3A) Ashkenazi Jewish descent Known BRCAmut carrier. Ashkenazi Jewish decent (at least one parent of Ashkenazi Jewish origin). No current or prior personal history of PDAC. Prior personal history of other malignancy including breast, ovarian or prostate cancer is allowed. Willing to provide blood specimens for correlative studies. BRCAmut carrier who is not related to a BRCAmut PDAC patient: (Control cohort 3B) non-Ashkenazi Jewish descent Know n BRCAmut carrier. No current or prior personal history of PDAC. Prior personal history of other malignancy including breast, ovarian, or prostate cancer is allowed. Willing to provide blood specimens for correlative studies. Non-BRCAmut carriers with histologically proven PDAC: (Control cohort 4) Tested for and negative for the BRCA founder mutations. Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin). Not related to known BRCAmut carrier. 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. 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. Willing to provide blood specimens for correlative studies. 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 Exclusion Criteria: Individuals will be excluded from the Registry if they: Are unable to sign informed consent for medical or other reasons. Do not speak English (MSK and UPenn) or do not speak English or Hebrew (BCGC Sites). Are under 21 years of age. Not willing to provide blood samples for correlative studies.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BRCAmut carrier relatives of a BRCAmut PDAC patient<br>Who themselves have no known prior or active personal history of non-PDAC malignancy (e.g. breast , ovarian cancer or prostate cancer) | Behavioral: The risk assessment questionnaire<br> <br> Other: Blood specimens<br> <br> |
| BRCAmut carrier relatives of a BRCA mutation PDAC<br>Patient who themselves have a known prior or active breast, ovarian cancer or prostate cancer | Behavioral: The risk assessment questionnaire<br> <br> Other: Blood specimens<br> <br> |
| BRCAmut carriers<br>who are not related to a BRCAmut PDAC patient | Behavioral: The risk assessment questionnaire<br> <br> Other: Blood specimens<br> <br> Other: tumor tissue samples will be requested<br> <br> |
| AJ PDAC patients<br>who are proven non-BRCAmut carriers. | Behavioral: The risk assessment questionnaire<br> <br> Other: Blood specimens<br> <br> Other: tumor tissue samples will be requested<br> <br> |
| AJ first or second degree relatives of an AJ PDAC patient from a multiplex family<br>A family with at least two first or second degree relatives w ho have had PDAC. | Behavioral: The risk assessment questionnaire<br> <br> Other: Blood specimens<br> <br> Other: tumor tissue samples will be requested<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prospective Registry | Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRCA Mutation Carriers, PDAC carriers, BRCAmut carriers, Registry, 13-217