A Registry for BRCA Mutation Carriers With Pancreatic Duc... | NCT01983410

Status Module

Name	Class
Abramson Cancer Center at Penn Medicine	OTHER
Shaare Zedek Medical Center	OTHER
Sheba Medical Center	OTHER_GOV
Dana-Farber Cancer Institute

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
BRCAmut carrier relatives of a BRCAmut PDAC patient	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 Other: Blood specimens
BRCAmut carrier relatives of a BRCA mutation PDAC	Patient who themselves have a known prior or active breast, ovarian cancer or prostate cancer	Behavioral: The risk assessment questionnaire Other: Blood specimens
BRCAmut carriers	who are not related to a BRCAmut PDAC patient	Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested
AJ PDAC patients	who are proven non-BRCAmut carriers.	Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested
AJ first or second degree relatives of an AJ PDAC patient from a multiplex family	A family with at least two first or second degree relatives w ho have had PDAC.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The risk assessment questionnaire	Behavioral		AJ PDAC patients AJ first or second degree relatives of an AJ PDAC patient from a multiplex family BRCAmut carrier relatives of a BRCA mutation PDAC

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

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Basking Ridge		Basking Ridge	New Jersey	07920	United States
Memorial Sloan Kettering Monmouth