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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

August 8, 2012
August 20, 2014
June 2007
September 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01662609 on ClinicalTrials.gov Archive Site
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Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital
Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Individuals potentially at high-risk for developing pancreatic cancer.

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
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.
Intervention: Procedure: Endoscopic Ultrasound (EUS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
September 2017
September 2017   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Yes
United States
 
NCT01662609
MCC-14882
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Not Provided
Principal Investigator: Jason Klapman, M.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP