A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Recruiting at 12 trial locations

Overseen By Kenneth H Yu, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Under 21, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Kelsen, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Registry Establishment

Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies

3 years

Follow-up

Participants are monitored for safety and effectiveness after registry establishment

6 months

Treatment Details

Interventions

• Blood specimens
• The risk assessment questionnaire
• tumor tissue samples will be requested

Participant Groups

Group I: BRCAmut carriers Experimental Treatment 3 Interventions

who are not related to a BRCAmut PDAC patient

Group II: BRCAmut carrier relatives of a BRCAmut PDAC patient Experimental Treatment 2 Interventions

Who themselves have no known prior or active personal history of non-PDAC malignancy (e.g. breast , ovarian cancer or prostate cancer)

Group III: BRCAmut carrier relatives of a BRCA mutation PDAC Experimental Treatment 2 Interventions

Patient who themselves have a known prior or active breast, ovarian cancer or prostate cancer

Group IV: AJ first or second degree relatives of an AJ PDAC patient from a multiplex family Experimental Treatment 3 Interventions

A family with at least two first or second degree relatives w ho have had PDAC.

Group V: AJ PDAC patients Experimental Treatment 3 Interventions

who are proven non-BRCAmut carriers.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Abramson Cancer Center of the University of Pennsylvania

Collaborator

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Collaborator

Trials

425

Recruited

464,000+

Shaare Zedek Medical Center

Collaborator

Trials

213

Recruited

53,600+

Sheba Medical Center

Collaborator

Trials

741

Recruited

2,841,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+