Pancreatic Ductal AdenocarcinomaNCT01983410
A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
An observational study of Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- The risk assessment questionnaire, Blood specimens and tumor tissue samples will be requested
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 4 Nov 2013to Nov 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: BRCA mutation carriers with PDAC will be identified by the PIs, co-investigators and by the research staff at all participating sites.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, 11724
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College (Specimen Analysis)
New York, New York
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Israel3 sites
Shaare Zedek Medical Center
Jerusalem
Weizmann Institute of Science (Specimen Analysis)
Rehovot
Sheba Medical Center
Tel HaShomer
About this study
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- The risk assessment questionnaire, Blood specimens, tumor tissue samples will be requested
- Keywords
- BRCA Mutation Carriers, PDAC carriers, BRCAmut carriers, Registry, 13-217
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The risk assessment questionnaireBehavioural
Blood specimensOther
tumor tissue samples will be requestedOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: The risk assessment questionnaire; Other: 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 Receives: Behavioral: The risk assessment questionnaire; Other: Blood specimens | |
| BRCAmut carriers | who are not related to a BRCAmut PDAC patient Receives: Behavioral: The risk assessment questionnaire; Other: Blood specimens; Other: tumor tissue samples will be requested | |
| AJ PDAC patients | who are proven non-BRCAmut carriers. Receives: Behavioral: The risk assessment questionnaire; Other: Blood specimens; Other: 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. Receives: Behavioral: The risk assessment questionnaire; Other: Blood specimens; Other: tumor tissue samples will be requested |
What is being measured
The primary outcome is the main question the study is designed to answer.
prospective Registry
Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start4 Nov 2013
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abramson Cancer Center at Penn Medicine, Shaare Zedek Medical Center, Sheba Medical Center, Dana-Farber Cancer Institute, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- David Kelsen, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983410
- Sponsor's protocol ID
- 13-217
- Status last verified
- Dec 2025
- First submitted
- 4 Nov 2013
- Last updated
- 30 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01983410
- Acronym / sponsor ID
- 13-217
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- BRCA Mutation Carriers, PDAC carriers, BRCAmut carriers, Registry, 13-217
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Abramson Cancer Center at Penn Medicine, Shaare Zedek Medical Center, Sheba Medical Center, Dana-Farber Cancer Institute, Johns Hopkins University
- Study start
- 4 Nov 2013 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BRCAmut carrier relatives of a BRCAmut PDAC patient | – | Behavioral: The risk assessment questionnaire, Other: Blood specimensWho themselves have no known prior or active personal history of non-PDAC malignancy (e.g. breast , ovarian cancer or prostate cancer) |
| BRCAmut carrier relatives of a BRCA mutation PDAC | – | Behavioral: The risk assessment questionnaire, Other: Blood specimensPatient who themselves have a known prior or active breast, ovarian cancer or prostate cancer |
| BRCAmut carriers | – | Behavioral: The risk assessment questionnaire, Other: Blood specimens, Other: tumor tissue samples will be requestedwho are not related to a BRCAmut PDAC patient |
| AJ PDAC patients | – | Behavioral: The risk assessment questionnaire, Other: Blood specimens, Other: tumor tissue samples will be requestedwho are proven non-BRCAmut carriers. |
| AJ first or second degree relatives of an AJ PDAC patient from a multiplex family | – | Behavioral: The risk assessment questionnaire, Other: Blood specimens, Other: tumor tissue samples will be requestedA family with at least two first or second degree relatives w ho have had PDAC. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- BRCA mutation carriers with PDAC will be identified by the PIs, co-investigators and by the research staff at all participating sites.
Key inclusion criteria (61 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The risk assessment questionnaire | Behavioural | AJ PDAC patients, AJ first or second degree relatives of an AJ PDAC patient from a multiplex family, BRCAmut carrier relatives of a BRCA mutation PDAC, BRCAmut carrier relatives of a BRCAmut PDAC patient, BRCAmut carriers |
| Blood specimens | Other | AJ PDAC patients, AJ first or second degree relatives of an AJ PDAC patient from a multiplex family, BRCAmut carrier relatives of a BRCA mutation PDAC, BRCAmut carrier relatives of a BRCAmut PDAC patient, BRCAmut carriers |
| tumor tissue samples will be requested | Other | AJ PDAC patients, AJ first or second degree relatives of an AJ PDAC patient from a multiplex family, BRCAmut carriers |
Primary outcome
prospective Registry
Time frame: 3 years
Establishment of a BRCA mutation carriers PDAC Registry with appropriate control groups, and collection and storage of biological material for future studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kelsen, MD principal investigator
Memorial Sloan Kettering Cancer Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 61 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prospective Registry (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.