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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01662609
First received: August 8, 2012
Last updated: August 20, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]
    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
Study Start Date: June 2007
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662609

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Campos    813-745-8358    tiffany.campos@moffitt.org   
Principal Investigator: Jason Klapman, M.D.         
Sub-Investigator: Barbara Centeno, M.D.         
Sub-Investigator: Pamela Hodul, M.D.         
Sub-Investigator: Mokenge Malafa, M.D.         
Sub-Investigator: Thomas Sellers, Ph.D.         
Sub-Investigator: Shivakumar Vignesh, M.D.         
Sub-Investigator: Catherine Phelan, M.D., Ph.D.         
United States, Pennsylvania
Lehigh Valley Health Network Not yet 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:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01662609     History of Changes
Other Study ID Numbers: MCC-14882
Study First Received: August 8, 2012
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014