Philadelphia, Pennsylvania 19004


Purpose:

The study is a prospective, observational, case-control study evaluating the utility of endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2 mutations.


Criteria:

Inclusion Criteria: - Informed consent provided - Age greater than or equal to 18 Patients: - Able and willing to attend routine follow-up as advised BRCA2 Mutation Carriers - Patients with a history of BRCA2 Mutation, with or without manifestation of breast or ovarian cancer, over the age of 50. - Any BRCA2 patient who has a first degree or 2 second degree family members with a history or pancreatic cancer will initiate screening 10 years prior to the age of onset of the index pancreatic neoplasia. BRCA1, ATM, & PALB2 Mutation Carriers - Any BRCA1 patient who has a first degree or 2 second degree family members with a history or pancreatic cancer will initiate screening 10 years prior to the age of onset of the index pancreatic neoplasia. Exclusion Criteria: - Known infection with HIV, HBC, or HCV - Pregnancy Esophageal strictures prior to treatment - Zenkers Diverticulum prior to treatment - History of abnormal or post surgical (i.e. post-Roux-en-Y Gastric Bypass) foregut anatomy precluding endoscopic ultrasound examination of the pancreas.


Study is Available At:


Original ID:

UPCC 26214


NCT ID:

NCT02478892


Secondary ID:


Study Acronym:


Brief Title:

Screening for PDAC in BRCA1/2 Patients


Official Title:

Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With BRCA1/2 Mutations


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abramson Cancer Center of the University of Pennsylvania


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Anil Rustgi, MD
855-216-0098
PennCancerTrials@emergingmed.com

Study Dates

Start Date:May 2015
Completion Date:May 2023
Completion Type:Anticipated
Primary Completion Date:May 2022
Primary Completion Type:Anticipated
Verification Date:March 2019
Last Changed Date:March 21, 2019
First Received Date:June 19, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:identifying pancreatic neoplastic lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.
Time Frame:5 years
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:prophylactic endoscopic ultrasound
Description:The patients will be followed up clinically with routine, prophylactic endoscopic ultrasound surveillance every 12 months for a duration of 5 years.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Abramson Cancer Center of the University of Pennsylvania

Samples and Retentions

Study Population: patients at high risk for pancreatic cancer, specifically those with BRCA1/2 mutations.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.