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Completed

NCT Number: NCT03382678

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

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.

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Validation of EGID diagnosis

    Time frame: 10 months

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Rare Diseases (ORD)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2017
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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