Status:
RECRUITING
Pediatric cGVHD Symptom Scale
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
5+ years
Brief 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 bothers...
Detailed Description
Background: * Hematopoietic stem cell transplantation (HSCT) is a curative option for many children with cancer and certain genetic disorders. However, recipients of stem cell transplant must deal wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04044365
Start Date
October 2 2019
End Date
December 31 2026
Last Update
December 11 2025
Active Locations (13)
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1
Children's Hospital Colorado (CHCO)
Aurora, Colorado, United States, 80045
2
Children s National Medical Center (CNMC)
Washington D.C., District of Columbia, United States, 20010
3
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, United States, 30322
4
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611