Eosinophilic EsophagitisNCT03382678
CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
An observational study of Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2018to 1 Jul 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Child, Adult, Older adult
Study population: Individuals with EGID
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the detailed 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.
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Gastrointestinal Disorders
- Medical subject headings
- Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of EGID diagnosis
Assess the validity of self-reported EGID diagnosis by comparing to physician reports.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start4 Sep 2018
- Primary completion1 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382678
- Sponsor's protocol ID
- 2017-5652
- Other IDs
- 5U54AI117804-03
- Status last verified
- Aug 2021
- First submitted
- 19 Dec 2017
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
- ClinicalTrials.gov ID
- NCT03382678
- Acronym / sponsor ID
- 2017-5652
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with EGID
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of EGID diagnosis
Time frame: 10 months
Assess the validity of self-reported EGID diagnosis by comparing to physician reports.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Rare Diseases Clinical Research Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of EGID diagnosis (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.