Routine Screening for Eosinophilic Esophagitis in Patient... | NCT01028235

Studies
Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia

NCT01028235

Sponsor

San Antonio Uniformed Services Health Education Consortium

Status

Unknown status

Last Update Posted

Dec 9, 2009Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Dysphagia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2009

Last Update Posted Date

Dec 9, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

San Antonio Uniformed Services Health Education ConsortiumFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18
complaint of dysphagia

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonathan M Ricker, DO	Contact	210-292-6408		jonathan.ricker@lackland.af.mil
Scott McNeaer, DO	Contact	210-916-5244		scott.mcnear@amedd.army.mil

Overall Officials

Name	Affiliation	Role
Jonathan M Ricker, DO	San Antonio Uniformed Services Health Education Consortium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wilford Hall Medical Center	Recruiting	San Antonio	Texas	78236	United States

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided