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A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01983410
Recruitment Status : Recruiting
First Posted : November 14, 2013
Last Update Posted : August 13, 2020
Sponsor:
Collaborators:
Abramson Cancer Center of the University of Pennsylvania
Shaare Zedek Medical Center
Sheba Medical Center
Dana-Farber Cancer Institute
Johns Hopkins University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : November 4, 2013
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
 Behavioral: The risk assessment questionnaire
Other: 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
 Behavioral: The risk assessment questionnaire
Other: Blood specimens
BRCAmut carriers
who are not related to a BRCAmut PDAC patient
 Behavioral: The risk assessment questionnaire
Other: Blood specimens
Other: tumor tissue samples will be requested
AJ PDAC patients
who are proven non-BRCAmut carriers.
 Behavioral: The risk assessment questionnaire
Other: Blood specimens
Other: tumor tissue samples will be requested


Outcome Measures
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Primary Outcome Measures :
  1. prospective Registry [ Time Frame: 3 years ]
    Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies.


Biospecimen Retention:   Samples With DNA
Blood specimens tumor tissue samples will be requested

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
BRCA mutation carriers with PDAC will be identified by the PIs, co-investigators and by the research staff at all participating sites.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983410


Contacts
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Contact: David Kelsen, MD 646-888-4179
Contact: Kenneth Yu, MD 646-888-4188

Locations
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United States, New York
Cold Springs Harbor Laboratory (Specimen Analysis) Not yet recruiting
Cold Spring Harbor, New York, United States, 11724
Contact: David Tuveson, MD, PhD    516-367-5246      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: David Kelsen, MD    646-888-4179      
Contact: Kenneth Yu, MD    646-888-4188      
Principal Investigator: David Kelsen, MD         
Weill Cornell Medical College (Specimen Analysis) Not yet recruiting
New York, New York, United States
Contact: David Lyden, MD, PhD    212-746-3400      
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Ephrat Levy-Lahad, PhD         
Principal Investigator: Ephrat Levy-Lahad, PhD         
Weizmann Institute of Science (Specimen Analysis) Not yet recruiting
Reẖovot, Israel
Contact: Ruth Scherz-Shouval, MD, PhD    972-8-934-2299      
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Talia Golan, MD         
Contact: Eitan Friedman, MD         
Principal Investigator: Talia Golan, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Abramson Cancer Center of the University of Pennsylvania
Shaare Zedek Medical Center
Sheba Medical Center
Dana-Farber Cancer Institute
Johns Hopkins University
Investigators
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Principal Investigator: David Kelsen, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01983410    
Other Study ID Numbers: 13-217
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
BRCA Mutation Carriers
PDAC carriers
BRCAmut carriers
Registry
13-217
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms