Protocol For High-Risk Assessment, Screening, And Early Detection Of Pancreatic Cancer

Study Overview

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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Pancreatic Cancer

PROCEDURE: Endoscopic Ultrasound (EUS)

MCC-14882

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-08-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-10-06
First Submitted that Met QC Criteria 2012-08-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-10-07
First Posted (ACTUAL) 2012-08-10	Results First Posted N/A	Last Verified 2022-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Endoscopic Ultrasound (EUS) Participants 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) 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.

Participant Group/Arm

Intervention/Treatment

: Endoscopic Ultrasound (EUS) Participants

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)

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.

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
30 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Aamir Dam, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record