A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
NCT ID: NCT01983410
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
600 participants
OBSERVATIONAL
2013-11-04
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
The risk assessment questionnaire
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
The risk assessment questionnaire
Blood specimens
BRCAmut carriers
who are not related to a BRCAmut PDAC patient
The risk assessment questionnaire
Blood specimens
tumor tissue samples will be requested
AJ PDAC patients
who are proven non-BRCAmut carriers.
The risk assessment questionnaire
Blood specimens
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.
The risk assessment questionnaire
Blood specimens
tumor tissue samples will be requested
Interventions
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The risk assessment questionnaire
Blood specimens
tumor tissue samples will be requested
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
Yes
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Shaare Zedek Medical Center
OTHER
Sheba Medical Center
OTHER_GOV
Dana-Farber Cancer Institute
OTHER
Johns Hopkins University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Kelsen, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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13-217
Identifier Type: -
Identifier Source: org_study_id