A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Other: Blood specimens; Behavioral: The risk assessment questionnaire; Other: tumor tissue samples will be requested

Study type: Observational

Funder types: Other

Identifiers

NCT01983410

13-217

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

600 participants in 5 patient groups

BRCAmut carrier relatives of a BRCAmut PDAC patient

Description:

Who themselves have no known prior or active personal history of non-PDAC malignancy (e.g. breast , ovarian cancer or prostate cancer)

Treatment:

Behavioral: The risk assessment questionnaire

Other: Blood specimens

BRCAmut carrier relatives of a BRCA mutation PDAC

Description:

Patient who themselves have a known prior or active breast, ovarian cancer or prostate cancer

Treatment:

Behavioral: The risk assessment questionnaire

Other: Blood specimens

BRCAmut carriers

Description:

who are not related to a BRCAmut PDAC patient

Treatment:

Other: tumor tissue samples will be requested

Behavioral: The risk assessment questionnaire

Other: Blood specimens

AJ PDAC patients

Description:

who are proven non-BRCAmut carriers.

Treatment:

Other: tumor tissue samples will be requested

Behavioral: The risk assessment questionnaire

Other: Blood specimens

AJ first or second degree relatives of an AJ PDAC patient from a multiplex family

Description:

A family with at least two first or second degree relatives w ho have had PDAC.

Treatment:

Other: tumor tissue samples will be requested

Behavioral: The risk assessment questionnaire

Other: Blood specimens