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

NCT01662609 | Completed

• 1 other identifier: MCC-14882
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pancreatic Cancer

Keywords

pancreas; high-risk

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

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.

Also known as: ultrasound scope

Endoscopic Ultrasound (EUS) Participants

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals potentially at high-risk for developing pancreatic cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18105, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Aamir Dam, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 10, 2012
• Study Start: August 23, 2007
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

US (2)