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

This study is currently recruiting participants.
Verified November 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662609
First Posted: August 10, 2012
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose
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.

Condition Intervention
Pancreatic Cancer Procedure: Endoscopic Ultrasound (EUS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 75
Actual Study Start Date: June 1, 2007
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: ultrasound scope

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals potentially at high-risk for developing pancreatic cancer.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662609


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Natalie Burgess    813-745-4075    natalie.burgess@moffitt.org   
Contact: Jason Klapman, M.D.    813-745-4035    jason.klapman@moffitt.org   
Principal Investigator: Jason Klapman, M.D.         
Sub-Investigator: Barbara Centeno, M.D.         
Sub-Investigator: Pamela Hodul, M.D.         
Sub-Investigator: Jenny Permuth, Ph.D.         
Sub-Investigator: Catherine Phelan, M.D., Ph.D.         
United States, Pennsylvania
Lehigh Valley Health Network Active, not recruiting
Allentown, Pennsylvania, United States, 18105
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Jason Klapman, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01662609     History of Changes
Other Study ID Numbers: MCC-14882
First Submitted: August 8, 2012
First Posted: August 10, 2012
Last Update Posted: December 1, 2017
Last Verified: November 2017

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
pancreas
high-risk

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases