Ovarian Cancer Clinical Trial

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

600

Study ID:

NCT01983410

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 9 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States More Info
David Kelsen, MD
Contact
646-888-4179
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
David Kelsen, MD
Contact
646-888-4179
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States More Info
David Kelsen, MD
Contact
646-888-4179
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor New York, 11724, United States More Info
David Tuveson, MD, PhD
Contact
516-367-5246
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
David Kelsen, MD
Contact
646-888-4179
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
David Kelsen, MD
Contact
646-888-4179
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
David Kelsen, MD
Contact
646-888-4179
Kenneth Yu, MD
Contact
646-888-4188
David Kelsen, MD
Principal Investigator
Weill Cornell Medical College (Specimen Analysis)
New York New York, , United States More Info
David Lyden, MD, PhD
Contact
212-746-3400
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States More Info
David Kelsen, MD
Contact
646-888-4179
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia Pennsylvania, 19104, United States
Shaare Zedek Medical Center
Jerusalem , , Israel More Info
Ephrat Levy-Lahad, PhD
Contact
Ephrat Levy-Lahad, PhD
Principal Investigator
Weizmann Institute of Science (Specimen Analysis)
Reẖovot , , Israel More Info
Ruth Scherz-Shouval, MD, PhD
Contact
972-8-934-2299
Sheba Medical Center
Tel Hashomer , , Israel More Info
Talia Golan, MD
Contact
Eitan Friedman, MD
Contact
Talia Golan, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

600

Study ID:

NCT01983410

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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