NCT01983410

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
2 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2013Nov 2026

First Submitted

Initial submission to the registry

November 4, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

13 years

First QC Date

November 4, 2013

Last Update Submit

December 23, 2025

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

BRCA Mutation CarriersPDAC carriersBRCAmut carriersRegistry13-217

Outcome Measures

Primary Outcomes (1)

  • prospective Registry

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

    3 years

Study Arms (5)

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 questionnaireOther: 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 questionnaireOther: Blood specimens

BRCAmut carriers

who are not related to a BRCAmut PDAC patient

Behavioral: The risk assessment questionnaireOther: Blood specimensOther: tumor tissue samples will be requested

AJ PDAC patients

who are proven non-BRCAmut carriers.

Behavioral: The risk assessment questionnaireOther: Blood specimensOther: tumor tissue samples will be requested

AJ first or second degree relatives of an AJ PDAC patient from a multiplex family

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

Behavioral: The risk assessment questionnaireOther: Blood specimensOther: tumor tissue samples will be requested

Interventions

The risk assessment questionnaireBEHAVIORAL
AJ PDAC patientsAJ first or second degree relatives of an AJ PDAC patient from a multiplex familyBRCAmut carrier relatives of a BRCA mutation PDACBRCAmut carrier relatives of a BRCAmut PDAC patientBRCAmut carriers
Blood specimensOTHER
AJ PDAC patientsAJ first or second degree relatives of an AJ PDAC patient from a multiplex familyBRCAmut carrier relatives of a BRCA mutation PDACBRCAmut carrier relatives of a BRCAmut PDAC patientBRCAmut carriers
tumor tissue samples will be requestedOTHER
AJ PDAC patientsAJ first or second degree relatives of an AJ PDAC patient from a multiplex familyBRCAmut carriers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • +46 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York, 11724, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical College (Specimen Analysis)

New York, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Weizmann Institute of Science (Specimen Analysis)

Rehovot, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens tumor tissue samples will be requested

Study Officials

  • David Kelsen, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 14, 2013

Study Start

November 4, 2013

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

IL(3)US(10)