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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Procedure: Endoscopic Ultrasound (EUS)

Study type: Observational

Funder types: Other

Identifiers

NCT01662609

MCC-14882

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 1 patient group

Endoscopic Ultrasound (EUS) Participants

Description:

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.

Treatment:

Procedure: Endoscopic Ultrasound (EUS)