CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

Eosinophilic Esophagitis Clinical Trial

Official title:

CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382678
• Other study ID #: 2017-5652
• Secondary ID: 5U54AI117804-03
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

All individuals with EGID and enrolled in the RDCRN CEGIR CR will be invited to participate in this survey. As of 04/28, 1567 EGID patients have enrolled in CEGIR CR [EoE=1,217, EG=56, EGE=65, EC=52; multiple diseases=177] The survey will be conducted through a pre-designed questionnaire. The questionnaire will be sent to participants via an introductory email wherein subjects will be informed about the purpose of this study. The questionnaire will gather self-reported clinical information (such as diagnosis, endoscopic procedures, histological findings in mucosal biopsies, and therapeutic plan). Consent will be obtained from participants to contact their physicians and allow their physicians to share relevant clinical information from their medical records. Physicians identified by participants will be emailed a website link which will take them to a questionnaire. This questionnaire is designed to gather relevant information as documented in the patient's clinical records. Physicians will be able to submit the information online. It is anticipated that responding to this questionnaire would take less than 10 minutes of their time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 1, 2020
• Est. primary completion date: May 1, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Center for Advancing Translational Science (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of EGID diagnosis	Assess the validity of self-reported EGID diagnosis by comparing to physician reports.	10 months

External Links

•   Rare Diseases Clinical Research Network website