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New tool aims to measure Kids' GVHD symptoms more accurately

NCT ID NCT04044365

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This study aims to create a symptom questionnaire specifically for children and teens living with chronic graft-versus-host disease (cGVHD) after a stem cell transplant. Current symptom scales are designed for adults, but children may describe their symptoms differently. Researchers will interview children aged 5-17 and their parents to develop and test a new scale that better captures how bothersome symptoms are, with the goal of improving care and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a better tool to understand and manage symptoms in children with chronic GVHD, improving their quality of life.
What could go wrong
This is an early-stage study focused on developing a questionnaire, not testing a treatment. It may not lead to direct improvements in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

139 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children of 5 to 17 years of age and their caregiver, who have undergone prior allogeneic stem cell transplant

Ages

5 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Pediatric Participant Inclusion Criteria: * Children aged 5 to 17 years old (Project 1) or children aged 8 to 17 years old (Project 2) * Clinical diagnosis of cGVHD following allogeneic stem cell transplant * Currently receiving systemic treatment for GVHD (including phototherapies), or has had systemic therapy for GVHD tapered to discontinuation within the past 12 months * No evidence of malignant disease relapse including molecular relapse and minimal residual disease. Patients with mixed chimerism are eligible to participate * Must have an eligible caregiver proxy who is willing to participate in the study. * Parent or guardian ability and willingness to sign a written informed consent document * Must be able to comprehend and speak the English language * Participants may enroll in both Project 1 and Project 2 of the study. Participation in Project 1 is not required in order to be eligible to participate in Project 2. Caregiver Proxy Inclusion Criteria * Adult (\>=18 years old) caregiver of a child participating in Project 1 or Project 2; OR Adult (\>=18 years old) caregiver of a child aged 5 to 7 years old who meets all Pediatric Participant Inclusion Criteria except Project 2 criteria noted above in the section Pediatric Participant Inclusion Criteria * Must be willing and able to provide informed consent * Must be able to comprehend and speak the English language EXCLUSOIN CRITERIA: Children may be excluded from this study if in the judgment of the Principal or Associate Investigator, the child is too ill, or the child s cognitive ability would compromise their ability to participate in study related procedures.

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft VS host disease

Contacts and locations

Locations

  • Children s National Medical Center (CNMC)

    Washington D.C., District of Columbia, 20010, United States

  • Children's & Women's Health Centre of British Columbia (CWHC of BC)

    Vancouver BC, Canada

  • Children's Healthcare of Atlanta - Egleston Hospital

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado (CHCO)

    Aurora, Colorado, 80045, United States

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Fred Hutchinson Cancer Center (FHCC)

    Seattle, Washington, 98109, United States

  • Hospital for Sick Children (SickKids)

    Toronto, Canada

  • Johns Hopkins Hospital (JHH)

    Baltimore, Maryland, 21287, United States

  • Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • St. Jude Children s Research Hospital

    Memphis, Tennessee, 38105, United States

  • Texas Children's Hospital (TCH)-Baylor

    Houston, Texas, 77030, United States

  • The University of Texas MD Anderson Cancer Institute

    Houston, Texas, 77030, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh - Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

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