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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01983410
Other study ID # 13-217
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2013
Est. completion date November 2025

Study information

Verified date December 2023
Source Memorial Sloan Kettering Cancer Center
Contact David Kelsen, MD
Phone 646-888-4179
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The risk assessment questionnaire

Other:
Blood specimens

tumor tissue samples will be requested


Locations

Country Name City State
Israel Shaare Zedek Medical Center Jerusalem
Israel Weizmann Institute of Science (Specimen Analysis) Re?ovot
Israel Sheba Medical Center Tel Hashomer
United States Memorial Sloan Kettering Basking Ridge Basking Ridge 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 Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
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 Abramson Cancer Center at University of Pennsylvania Medical Center Philadelphia Pennsylvania
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (6)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Abramson Cancer Center at Penn Medicine, Dana-Farber Cancer Institute, Johns Hopkins University, Shaare Zedek Medical Center, Sheba Medical Center

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary prospective Registry Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies. 3 years
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