ACTIVE_NOT_RECRUITING

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

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Pancreatic Ductal AdenocarcinomaBRCA Mutation CarriersPDAC carriersBRCAmut carriersRegistry13-217

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2013-11-04
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01983410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BRCA mutation carrier is defined as a person with any mutation of the BRCA gene, including BRCA1, or BRCA2. PALB2mut patients are also eligible.
  2. * Relative of a BRCA PDAC patient is defined as a first-degree relative, which includes, parents, siblings or children.
  3. * Known BRCA mutation carrier.
  4. * Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin).
  5. * Histologic proof of primary pancreatic ductal adenocarcinoma.
  6. * May have either potentially curable (resectable) primary PDAC, localized but unresectable primary PDAC, or metastatic (stage IV) PDAC.
  7. * Prior personal history of other malignancy; either prior or currently active, including breast , ovarian or prostate cancer is allowed.
  8. * 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.
  9. * Willing to provide blood specimens for correlative studies.
  10. * 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.
  11. * Know n BRCA mutation carrier.
  12. * Histologic proof of primary pancreatic ductal adenocarcinoma.
  13. * May have either potentially curable (resectable) primary PDAC, localized but unresectable primary PDAC, or metastatic (stage IV) PDAC.
  14. * Prior personal history of other malignancy; either prior or currently active, including breast, ovarian, or prostate cancer is allowed.
  15. * 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.
  16. * Willing to provide blood specimens for correlative studies.
  17. * 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.
  18. * Known BRCA mutation carrier.
  19. * Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin).
  20. * No current or prior history of PDAC.
  21. * Relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer
  22. * Willing to provide blood specimens for correlative studies.
  23. * Know n BRCA mutation carrier.
  24. * No current or prior history of PDAC.
  25. * First or second degree relative of a BRCAmut PDAC patient; no prior or active personal history of breast, ovarian, or prostate cancer.
  26. * Willing to provide blood specimens for correlative studies.
  27. * Known BRCA mutation carrier.
  28. * Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin).
  29. * No current or prior history of PDAC.
  30. * Relative of a BRCAmut PDAC patient.
  31. * Prior or active personal history of any BRCA-related cancer.
  32. * Willing to provide blood specimens for correlative studies.
  33. * Know n BRCA mutation carrier.
  34. * No current or prior history of PDAC.
  35. * First or second degree relative of a BRCAmut PDAC patient.
  36. * Prior or active personal history of any BRCA-related cancer.
  37. * Willing to provide blood specimens for correlative studies.
  38. * Known BRCAmut carrier.
  39. * Ashkenazi Jewish decent (at least one parent of Ashkenazi Jewish origin).
  40. * No current or prior personal history of PDAC.
  41. * Prior personal history of other malignancy including breast, ovarian or prostate cancer is allowed.
  42. * Willing to provide blood specimens for correlative studies.
  43. * Know n BRCAmut carrier.
  44. * No current or prior personal history of PDAC.
  45. * Prior personal history of other malignancy including breast, ovarian, or prostate cancer is allowed.
  46. * Willing to provide blood specimens for correlative studies.
  47. * Ashkenazi Jewish Descent (at least one parent of Ashkenazi Jewish origin).
  48. * Not related to known BRCAmut carrier.
  49. * 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.
  50. * 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.
  51. * Willing to provide blood specimens for correlative studies.
  52. * 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
  1. * Individuals will be excluded from the Registry if they:
  2. * 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).
  3. * Are under 21 years of age.
  4. * Not willing to provide blood samples for correlative studies.

Contacts and Locations

Principal Investigator

David Kelsen, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, 11724
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Weill Cornell Medical College (Specimen Analysis)
New York, New York
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • David Kelsen, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-11-04
Study Completion Date2025-11

Study Record Updates

Study Start Date2013-11-04
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • BRCA Mutation Carriers
  • PDAC carriers
  • BRCAmut carriers
  • Registry
  • 13-217

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma