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Clinical Trials in Israel / NCT01983410
Active, not recruiting Observational

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

NCT01983410 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2013-11-04
Last updated
2025-12-30

Condition(s) studied

Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

The risk assessment questionnaireBlood specimenstumor tissue samples will be requested

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (13)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01983410 on ClinicalTrials.gov ↗ ← All trials in Israel