A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Running, not enrolling

Conditions studied: Pancreatic Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT01983410

Run by

Memorial Sloan Kettering Cancer Center

People needed

600

Starts

2013-11-04

Expected to finish

2026-11-01

Last updated by the study team

2025-12-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Cold Springs Harbor Laboratory (Specimen Analysis) — Cold Spring Harbor, New York, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College (Specimen Analysis) — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• Abramson Cancer Center at University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Shaare Zedek Medical Center — Jerusalem, Israel
• Weizmann Institute of Science (Specimen Analysis) — Rehovot, Israel
• Sheba Medical Center — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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