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New registry aims to unlock why BRCA mutations lead to pancreatic cancer

NCT ID NCT01983410

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study creates a registry for people with BRCA or PALB2 gene mutations who have pancreatic cancer, along with their close relatives. Researchers will collect medical information, blood samples, and tumor tissue to better understand why pancreatic cancer develops in this group. No treatments are tested; the goal is to gather data for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could help researchers understand why some people with BRCA mutations develop pancreatic cancer, potentially pointing toward better screening or prevention strategies.
What could go wrong
This is an observational registry, not a treatment trial. It collects information and samples but does not test any intervention, so it cannot directly lead to a cure or therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2013

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

BRCA mutation carriers with PDAC will be identified by the PIs, co-investigators and by the research staff at all participating sites.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Abramson Cancer Center at University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-4283, United States

  • Cold Springs Harbor Laboratory (Specimen Analysis)

    Cold Spring Harbor, New York, 11724, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Shaare Zedek Medical Center

    Jerusalem, Israel

  • Sheba Medical Center

    Tel Litwinsky, Israel

  • Weill Cornell Medical College (Specimen Analysis)

    New York, New York, United States

  • Weizmann Institute of Science (Specimen Analysis)

    Rehovot, Israel

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Other studies related to the condition(s) this trial covers.