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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound (EUS)

Procedure

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.

Other names: ultrasound scope

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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2022
Study completion: 2022
First posted: Aug 10, 2012
Registry last updated: Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed