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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662609
• Other study ID #: MCC-14882
• Status: Completed
• Start date: August 23, 2007
• Est. completion date: August 16, 2022

Study information

• Verified date: October 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website