A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.

• For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.

• The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.

• The individual is at least 50 years old or 10 years younger than the youngest relative with PC.

• ECOG Performance Status of 0-1.

• No known contraindications to MRI examination or gadolinium contrast.

• Willing to undergo MRI and screening for metal implants or metal injury.

• Estimated GFR \>29 mL/min

• Ability to provide informed consent.

⁃ Willing to return to study site for all study assessments.

Locations
United States
Connecticut
Nuvance Health
RECRUITING
Norwalk
Contact Information
Primary
Tammy Lo, APRN
Tammy.Lo@nuvancehealth.org
Backup
Pramila Krumholtz, RN
Pramila.Krumholtz@nuvancehealth.org
Time Frame
Start Date: 2016-11
Estimated Completion Date: 2026-11
Participants
Target number of participants: 200
Treatments
FAMILIAL PANCREATIC CANCER and/or GENE MUTATION
An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.
Sponsors
Leads: Nuvance Health

This content was sourced from clinicaltrials.gov