A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Behavioral: The risk assessment questionnaire; Other: Blood specimens; Other: tumor tissue samples will be requested

• Registration Number: NCT01983410
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-04
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
prospective Registry	3 years	Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies.

Trial Locations

Locations (13)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Weizmann Institute of Science (Specimen Analysis); 🇮🇱 Reẖovot, Israel

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Weill Cornell Medical College (Specimen Analysis); 🇺🇸 New York, New York, United States

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Cold Springs Harbor Laboratory (Specimen Analysis); 🇺🇸 Cold Spring Harbor, New York, United States

Abramson Cancer Center at University of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States