Clinical Trial 14882

Cancer Type: Gastrointestinal Tumor

Study Type: Screening
Phase of Study: Pilot


    Study Title

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


    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.


    1. To establish a cohort of individuals at high-risk for the development of pancreatic cancer from patients at Moffitt Cancer Center with self-reported risk factors or relatives of patients with familial pancreatic cancer. 2. To determine whether targeted screening of thee high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals and biospecimen collection can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer. 3. To determine the prevalence and stage of early cancers in asymptomatic high-risk individuals and relatives of patients with familial pancreatic cancer. To obtain permission from the study participants to use their self-reported risk factors, biospecimens collected and medical records obtained from the screening program to identify patients who may be eligible for future clinical trials involving early detection and treatment of pancreatic cancer.

    Inclusion Criteria

  • One of the following high-risk groups
  • Patients with at least 1 FDR affected from a familial PC kindred with at least 2 members affected
  • Patients at least 40yrs old or 10yrs 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
  • Patients with Familial Adenomatous Polyposis (FAP) or Hereditary Nonpolyposis colorectal cancer (HNPCC)
  • 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