A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT01983410 |
Recruitment Status :
Recruiting
First Posted : November 14, 2013
Last Update Posted : August 13, 2020
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Condition or disease | Intervention/treatment |
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Pancreatic Ductal Adenocarcinoma | Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma |
Actual Study Start Date : | November 4, 2013 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2021 |
Group/Cohort | Intervention/treatment |
---|---|
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)
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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
|
Behavioral: The risk assessment questionnaire Other: Blood specimens |
BRCAmut carriers
who are not related to a BRCAmut PDAC patient
|
Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested |
AJ PDAC patients
who are proven non-BRCAmut carriers.
|
Behavioral: The risk assessment questionnaire Other: Blood specimens Other: tumor tissue samples will be requested |
- 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.
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
- 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.
BRCA mutation carrier, relative of a BRCA PDAC patients, without PDAC or other BRCAmut related malignancy: (Control Cohort 1)
- 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.
BRCAmut Carrier relative of a BRCAmut PDAC patient who themselves have prior or active BRCAmut related malignancy (Control Cohort 2):
- 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 who is not related to a BRCAmut PDAC patient: (Control cohort 3) 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983410
Contact: David Kelsen, MD | 646-888-4179 | ||
Contact: Kenneth Yu, MD | 646-888-4188 |
United States, New York | |
Cold Springs Harbor Laboratory (Specimen Analysis) | Not yet recruiting |
Cold Spring Harbor, New York, United States, 11724 | |
Contact: David Tuveson, MD, PhD 516-367-5246 | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: David Kelsen, MD 646-888-4179 | |
Contact: Kenneth Yu, MD 646-888-4188 | |
Principal Investigator: David Kelsen, MD | |
Weill Cornell Medical College (Specimen Analysis) | Not yet recruiting |
New York, New York, United States | |
Contact: David Lyden, MD, PhD 212-746-3400 | |
United States, Pennsylvania | |
Abramson Cancer Center at University of Pennsylvania Medical Center | Active, not recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Israel | |
Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel | |
Contact: Ephrat Levy-Lahad, PhD | |
Principal Investigator: Ephrat Levy-Lahad, PhD | |
Weizmann Institute of Science (Specimen Analysis) | Not yet recruiting |
Reẖovot, Israel | |
Contact: Ruth Scherz-Shouval, MD, PhD 972-8-934-2299 | |
Sheba Medical Center | Recruiting |
Tel Hashomer, Israel | |
Contact: Talia Golan, MD | |
Contact: Eitan Friedman, MD | |
Principal Investigator: Talia Golan, MD |
Principal Investigator: | David Kelsen, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01983410 |
Other Study ID Numbers: |
13-217 |
First Posted: | November 14, 2013 Key Record Dates |
Last Update Posted: | August 13, 2020 |
Last Verified: | August 2020 |
BRCA Mutation Carriers PDAC carriers BRCAmut carriers Registry 13-217 |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |