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NCT04044365 · ClinicalTrials.gov registry record
Pediatric cGVHD Symptom Scale
A clinical trial of Graft Vs Host Disease, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 420
- Enrollment target
- 17
- Study locations
NCT04044365: Recruiting study of Graft Vs Host Disease, sponsored by National Cancer Institute (NCI).
NCT04044365 is a study of Graft Vs Host Disease that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 420 participants, above the 126-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (233% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044365, a study of Graft Vs Host Disease, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 420 participants
- Enrollment target
- 17
- Study locations
Study Summary
Background: Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires that measure thesymptoms caused by cGVHD are designed for adults. Children/adolescents may not describe their symptoms in the same way. The goal of this research is to improve the way we measure how bothersome these symptoms are for children/adolescents living with cGVHD. Objective: To develop a questionnaire (The Pediatric cGHVD Symptom Scale) for children/adolescents living with cGVHD to identify the symptoms they are experiencing and describe how bothersome those symptoms are to them. An additional goal is to design a parent/guardian companion questionnaire that can be used to capture the symptom experiences of very young children who may not be able to complete a questionnaire. Eligibility: Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian.. Design: This study consists of 2 projects. Children/adolescents with cGVHD and their parent/guardianparticipants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17. In project 1, participants will complete an age-appropriate questionnaire about cGVHD symptoms. The questionnaire will ask about the child/adolescent s physical functioning and emotional well-being. The parent/guardian will out fill out a companion questionnaire online. The child/adolescent will then review their completed questionnaire during an interview with a researcher and will be asked whether the questions about their symptoms were difficult to understand. The parent/guardian and child/adolescent will then be interviewed together to further explore their responses to the questionnaires. Interviews will be done in person, by phone, and online. . Based on what is learn
Primary Outcome
To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
Conditions Studied
Study Locations (17)
Maryland
- Johns Hopkins Hospital (JHH) - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Texas
- Texas Children's Hospital (TCH)-Baylor - Houston
- The University of Texas MD Anderson Cancer Institute - Houston
Other
- Hospital for Sick Children (SickKids) - Toronto
- Children's & Women's Health Centre of British Columbia (CWHC of BC) - Vancouver BC
Arizona
- Phoenix Children's Hospital - Phoenix
California
- City of Hope - Duarte
Colorado
- Children's Hospital Colorado (CHCO) - Aurora
District of Columbia
- Children s National Medical Center (CNMC) - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2019-10-02 |
| Est. Completion | 2026-12-31 |
What NCT04044365 shows while recruiting
NCT04044365 is an observational study that tracks outcomes without assigning an intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (233% higher).
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 0 interventions.
NCT04044365 lists 17 locations in 14 states (Maryland, Texas, Other).
Frequently Asked Questions
What is clinical trial NCT04044365 about?
NCT04044365 is a clinical study titled "Pediatric cGVHD Symptom Scale". Background: Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires tha...
What is the current status of trial NCT04044365?
This trial is currently recruiting. The enrollment target is 420 participants. The study started on 2019-10-02. Estimated completion is 2026-12-31.
What conditions does trial NCT04044365 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
Who is sponsoring clinical trial NCT04044365?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04044365 being conducted?
This trial has 17 study locations across Arizona, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Graft Vs Host Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04044365's enrollment target sits among peer trials
420 3rd of 36 higher than 34 of 36 other Graft Vs Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft Vs Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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