Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease

Completed

Conditions studied: Graft vs Host Disease

In brief

Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100 days following transplantation and develops in 20-60% of transplant recipients. The incidence of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrelated donor bone marrow, the use of unmanipulated T cell-depleted bone marrow, and perhaps other factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics the clinical features of autoimmune diseases. The manifestations include skin changes (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss, polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody, anti-erythrocyte antibodies, and anti-platelet antibodies.

Key facts

Study ID

NCT00632658

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

24

Starts

2008-01-01

Expected to finish

2011-07-01

Last updated by the study team

2019-10-08

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 5-18 years of age
• Prior allogeneic Stem Cell Transplant, with any graft source, donor type, and GVHD prophylaxis allowed
• Clinical diagnosis of cGVHD
• Need for systemic treatment, defined as any medication or intervention delivered
• No evidence of primary disease relapse
• Signed, informed consent, and if applicable, adolescent assent

You may not qualify if…

• Inability to give signed informed consent

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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