Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With Inherited Genetic Risk

NCT02478892 | Recruiting DMC

• 1 other identifier: UPCC 26214
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2, ATM, or PALB2 mutations.

Conditions

Pancreatic Cancer

Keywords

high risk; specifically those with BRCA1/2 mutations

Outcome Measures

Primary Outcomes (1)

• identifying pancreatic neoplastic lesions lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.

  The primary objective of the study is the observational screening of patients with BRCA1/2, ATM, or, PALB2 mutations for pancreatic neoplastic lesions, to assess for both the feasibility of this approach in this high risk population as well as to better establish the incidence of these lesions in this cohort.

  10 years

Interventions

Blood sample collection for research OTHER

Up to 40mL of blood may be collected for analysis at each screening examination.

Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomen OTHER

Participants in this study should be undergoing pancreatic cancer screening with endoscopic ultrasound or MRI as part of their standard care. These should typically be done at least every 12 months, and the imaging tests will be ordered as routine clinical tests and will be billed to the participant's insurance. This study does not cover the costs of these screening tests, however the study will track the results of these screening tests.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at high risk for pancreatic cancer, specifically those with pathogenic germline variant in BRCA1, BRCA2, ATM, or PALB2 who will be undergoing pancreatic cancer screening as part of their routine clinical care.

You may qualify if:

• Age \>= 18
• Documented germline pathogenic or likely pathogenic BRCA1, BRCA2, ATM, or PALB2 mutation
• If no history of PDAC in a first or second degree relative, age \>= 50
• If there is a history of PDAC in a first or second degree relative, minimum age of eligibility is 10 years younger than the age of onset of the youngest relative with pancreatic cancer

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19004, United States

RECRUITING

Related Publications (1)

• Katona BW, Long JM, Ahmad NA, Attalla S, Bradbury AR, Carpenter EL, Clark DF, Constantino G, Das KK, Domchek SM, Dudzik C, Ebrahimzadeh J, Ginsberg GG, Heiman J, Kochman ML, Maxwell KN, McKenna DB, Powers J, Shah PD, Wangensteen KJ, Rustgi AK. EUS-based Pancreatic Cancer Surveillance in BRCA1/BRCA2/PALB2/ATM Carriers Without a Family History of Pancreatic Cancer. Cancer Prev Res (Phila). 2021 Nov;14(11):1033-1040. doi: 10.1158/1940-6207.CAPR-21-0161. Epub 2021 Aug 2.

  PMID: 34341011 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Up to 40mL of blood may be collected for analysis at each screening examination.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Bryson Katona, MD

CONTACT

Bryson.Katona@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 23, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)