NCT03382678

Brief Summary

The purpose of this study is to validate the online cohort of EGID patients enrolled in the RDCRN CEGIR CR. In order to achieve this objective, the investigators will determine the agreement between self-reported EGID information by the enrollees and their physician's report and medical records. All participants enrolled in the RDCRN CEGIR CR with EGIDs will be invited via email to participate in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

December 19, 2017

Last Update Submit

August 31, 2021

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

  • Validation of EGID diagnosis

    Assess the validity of self-reported EGID diagnosis by comparing to physician reports.

    10 months

Eligibility Criteria

Age0 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with EGID

You may qualify if:

  • Enrolled in the RDCRN CEGIR Contact Registry, and with Internet access.
  • Diagnosis of EGID (EoE, EG, EGE, EE and/or EC)
  • Age: all ages. Parents/guardian of children \< 18 years of age will respond to the questionnaire on behalf of their child.

You may not qualify if:

  • Inability to provide informed consent and complete survey
  • Unaffected family members of EGID patients
  • European Union participants who did not complete General Data Protection Regulation requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

September 4, 2018

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

US(2)