A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma



Status:Recruiting
Healthy:No
Age Range:21 - Any
Updated:11/22/2018
Start Date:November 4, 2013
End Date:November 2020
Contact:David Kelsen, MD
Phone:646-888-4179

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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.


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

- 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.

BRCA mutation carrier, relative of a BRCA PDAC patients, without PDAC or other BRCAmut
related malignancy: (Control Cohort 1)

- 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.

BRCAmut Carrier relative of a BRCAmut PDAC patient who themselves have prior or active
BRCAmut related malignancy (Control Cohort 2):

- 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 who is not related to a BRCAmut PDAC patient: (Control cohort 3) 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.

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.
We found this trial at
3
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: David Kelsen, MD
Phone: 646-888-4179
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Jerusalem, 91031
Principal Investigator: Ephrat Levy-Lahad, PhD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Susan Domchek, MD
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Philadelphia, PA
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