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NCT01983410 | RECRUITING | Pancreatic Ductal Adenocarcinoma

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
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.

Condition or disease

Pancreatic Ductal Adenocarcinoma

Intervention/treatment

The risk assessment questionnaire

Blood specimens

tumor tissue samples will be requested

Study Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : 2013-11-04
Estimated Primary Completion Date : 2025-11
Estimated Study Completion Date : 2025-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Location Details

NCT01983410

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

NOT YET RECRUITING

United States, New York

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York, United States, 11724

RECRUITING

United States, New York

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

NOT YET RECRUITING

United States, New York

Weill Cornell Medical College (Specimen Analysis)

New York, New York, United States,

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

ACTIVE NOT RECRUITING

United States, Pennsylvania

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States, 19104-4283

RECRUITING

Israel,

Shaare Zedek Medical Center

Jerusalem, Israel,

NOT YET RECRUITING

Israel,

Weizmann Institute of Science (Specimen Analysis)

Rabbovot, Israel,

RECRUITING

Israel,

Sheba Medical Center

Tel Hashomer, Israel,