A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

This study is currently recruiting participants.
Verified January 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Abramson Cancer Center of the University of Pennsylvania
Shaare Zedek Medical Center
Sheba Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01983410
First received: November 4, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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 Intervention
Pancreatic Ductal Adenocarcinoma
Behavioral: The risk assessment questionnaire
Other: Blood specimens
Other: tumor tissue samples will be requested

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • prospective Registry [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 500
Study Start Date: November 2013
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BRCAmut carrier relatives of the BRCAmut PDAC patient
Who have no known prior or active personal history of non-PDAC malignancy (e.g. breast or ovarian cancer)
Behavioral: The risk assessment questionnaire Other: Blood specimens
BRCAmut carrier relatives of the BRCA mutation PDAC
Patient with known prior or active breast and/or ovarian 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 MSK, UPenn, and the Israeli BCGC 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 (at MSKCC or at a participating center).
  • 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 or ovarian 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 or ovarian cancer.
  • Willing to provide blood specimens for correlative studies.

BRCAmut Carrier relative of BRCAmut PDAC patient with 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 breast or ovarian 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 or ovarian 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 (at MSKCC or at a participating center). 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983410

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

Locations
United States, New York
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         
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Susan Domchek, MD         
Principal Investigator: Susan Domchek, MD         
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Ephrat Levy-Lahad, PhD         
Principal Investigator: Ephrat Levy-Lahad, PhD         
Sheba Medical Center Not yet 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
Investigators
Principal Investigator: David Kelsen, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01983410     History of Changes
Other Study ID Numbers: 13-217
Study First Received: November 4, 2013
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
BRCA Mutation Carriers
PDAC carriers
BRCAmut carriers
Registry
13-217

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014