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Registry for BRCA Mutation Carriers with Pancreatic Cancer

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Observational Memorial Sloan Kettering Cancer Center · NCT01983410

This study is setting up a registry to gather information from people with pancreatic cancer who have BRCA or PALB2 gene mutations to better understand the disease and improve treatment options.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages21 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsradiation
Locations13 sites (Basking Ridge, New Jersey and 12 other locations)
Trial IDNCT01983410 on ClinicalTrials.gov

What this trial studies

This study aims to establish a registry for individuals who are carriers of BRCA or PALB2 mutations and have been diagnosed with pancreatic ductal adenocarcinoma (PDAC). By collecting data through risk assessment questionnaires, blood specimens, and tumor tissue samples, the researchers hope to gain insights into the development of pancreatic cancer in these specific genetic populations. The registry will facilitate a better understanding of the disease and potentially guide future treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include individuals with BRCA or PALB2 mutations who have been diagnosed with pancreatic ductal adenocarcinoma, particularly those of Ashkenazi Jewish descent.

Not a fit: Patients without BRCA or PALB2 mutations or those with other forms of pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved understanding and management of pancreatic cancer in BRCA mutation carriers.

How similar studies have performed: Other studies focusing on genetic mutations and cancer registries have shown promise, indicating that this approach may yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Basking Ridge, New Jersey and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Ductal AdenocarcinomaBRCA Mutation CarriersPDAC carriersBRCAmut carriersRegistry13-217
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.