Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Endoscopic Ultrasound (EUS)

• Registration Number: NCT01662609
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-10
• Primary Completion: 2022-08-16
• Study Completion: 2022-08-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Willingness to undergo radiographic evaluation if screening findings are abnormal

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Ultrasound (EUS) Participants	Endoscopic Ultrasound (EUS)	High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.

Primary Outcome Measures

Name	Time	Method
Number of Abnormalities Detected by EUS	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.

Trial Locations

Locations (2)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States