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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Endoscopic Ultrasound (EUS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic Ultrasound (EUS) Participants<br>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. | Procedure: Endoscopic Ultrasound (EUS)<br>* Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.<br>* Other names: ultrasound scope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Abnormalities Detected by EUS | 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. | Average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas, high-risk