NCT01028235

Brief Summary

The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 9, 2009

Status Verified

November 1, 2009

Enrollment Period

4 years

First QC Date

December 8, 2009

Last Update Submit

December 8, 2009

Conditions

Keywords

Eosinophilic Esophagitis

Study Arms (2)

Obstructive Dysphagia

Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc)

Non-obstructive Dysphagia

Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia

You may qualify if:

  • age \> 18
  • complaint of dysphagia

You may not qualify if:

  • pregnancy
  • age \<18
  • on inhaled steroids within the last 30 days
  • on systemic steroids in the last 30 days
  • known diagnosis of Eosinophilic Esophagitis
  • obvious obstructive etiology found at endoscopy
  • increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wilford Hall Medical Center

San Antonio, Texas, 78236, United States

RECRUITING

Brooke Army Medical Center

San Antonio, Texas, 78245, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 endoscopic biopsies from 5 locations: duodenum, stomach, distal esophagus, mid esophagus and proximal esophagus

MeSH Terms

Conditions

Deglutition DisordersEosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesEsophagitisGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jonathan M Ricker, DO

    San Antonio Uniformed Services Health Education Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

January 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 9, 2009

Record last verified: 2009-11

Locations