Clinical trial NCT01983410: A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
Official title: A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: BRCA Mutation Carriers
PDAC carriers
BRCAmut carriers
Registry
13-217
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Abramson Cancer Center at Penn Medicine
name: Shaare Zedek Medical Center
name: Sheba Medical Center
name: Dana-Farber Cancer Institute
name: Johns Hopkins University
First posted: 2013-11-14
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 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 outcomes:
measure: prospective Registry
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Cold Spring Harbor
country: United States
facility: Cold Springs Harbor Laboratory (Specimen Analysis)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College (Specimen Analysis)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania Medical Center
state: Pennsylvania
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science (Specimen Analysis)
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Kelsen, MD
role: PRINCIPAL_INVESTIGATOR
References: