Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital

H. Lee Moffitt Cancer Center and Research Institute2 sites in 1 country90 target enrollmentAugust 23, 2007

ConditionsPancreatic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 90
Locations: 2
Primary Endpoint: Number of Abnormalities Detected by EUS
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.

Registry

clinicaltrials.gov

Start Date

August 23, 2007

End Date

August 16, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
•If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
•If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
•Patients at least 40 years old or 10 years younger than the youngest affected individual
•Peutz-Jeghers Syndrome (PJS) patients age\>30
•Hereditary pancreatitis patients
•Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
•Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
•Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
•Willingness to undergo surgical evaluation for abnormal EUS/FNA finding

Exclusion Criteria

•Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
•Personal history of pancreatic adenocarcinoma
•Previous partial or complete resection of the pancreas for adenocarcinoma
•Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
•Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
•Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
•Life expectancy less than 5 years
•Pregnancy

Outcomes

Primary Outcomes

Number of Abnormalities Detected by EUS

Time Frame: Average of 5 years

To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.