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Barrett's Esophagus in Olmsted County

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943280
First received: July 20, 2009
Last updated: January 4, 2012
Last verified: January 2012

July 20, 2009
January 4, 2012
January 2009
January 2010   (final data collection date for primary outcome measure)
The primary outcome variable for this aim will be the number of subjects in each group that need to be contacted until 20 in each group agree to participate in this study. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00943280 on ClinicalTrials.gov Archive Site
To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Barrett's Esophagus in Olmsted County
Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study

To compare participation rates in screening for Barrett's Esophagus (BE) using sedated esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. An age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from Olmsted County11, 12 using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR conventional sedated endoscopy. The investigators will compare participation rates in the three arms.

To identify factors associated with non-participation in population screening for BE. The investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated Gastroesophageal Reflux questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by all targeted subjects. This preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Gastric, GE junction and esophagus tissue samples collected.

Non-Probability Sample

Olmsted county residents

Barrett's Esophagus
Not Provided
  • 1 EGD
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to EGD.
  • 2 Transnasal
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to Transnasal endoscopy.
  • 3 PillCam
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to PillCam.
Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Olmsted county resident

Exclusion Criteria:

  • History of known BE or endoscopy within the last 5 years;
  • History of progressive dysphagia;
  • Known Zenker's diverticulum;
  • Known epiphrenic diverticulum;
  • Known or suspected intestinal obstruction;
  • Cardiac pacemakers or other implanted electro-medical devices;
  • Pregnancy;
  • Patient expected to undergo MRI examination within 7 days after ingestion of the capsule;
  • History of prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy) within the last six months; pregnancy;
  • History of recurrent epistaxis, moved from Olmsted County or deceased;
  • Significant illnesses that might impair ability to complete questionnaires (e.g. metastatic cancer, major stroke); and
  • Any contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel [Plavix]).
Both
20 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943280
08-003642
No
Ganapathy A. Prasad, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Ganapathy A. Prasad, MD Mayo Clinic
Mayo Clinic
January 2012

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