Expired Study
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Chicago, Illinois 60611


Purpose:

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.


Study summary:

A large number of children with cGVHD have to deal with many years of a disfiguring and painful chronic illness with the side effects of long term steroid use. The number of stem cell transplants done in children is only growing given that we are now transplanting patients with a variety of nonmalignant disorders and given the use of alternative donor sources. The broad categories of limited and extensive cGVHD are recognized by clinicians, but are not particularly useful in clinical practice. Since cGVHD may involve almost every organ system adn since cGVHD constitutes a waxing and waning nature, cGVHD makes clinical management very difficult and complicated. Currently, there is a symptoms scale used in the adult population for measuring symptom burden for adults with cGVHD. This scale is called the "Lee Symptoms Scale". The purpose of this project is to develop a scale that is similar in design to the Lee Scale, but it is specifically designed to measure the burden of cGVHD in the pediatric population


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - Inability to give signed informed consent


Study is Available At:


Original ID:

SCT 0208B


NCT ID:

NCT00632658


Secondary ID:


Study Acronym:

cGVHD


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

5 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ann & Robert H Lurie Children's Hospital of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Reggie E Duerst, MD
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago

Study Dates

Start Date:January 2008
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:July 2011
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 4, 2019
First Received Date:March 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:To develop a Pediatric Chronic GVHD Symptoms Scale (PCSS) that reliably measures the disease specific burden of chronic GVHD in children
Time Frame:One Day Interview will be performed
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Patients with cGVHD
Description:Pediatric Patients with cGVHD will be asked to participate in an interview with their Physician. The interview will ask the pediatric patients questions about their cGVHD. The interview will be audio-recorded.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ann & Robert H Lurie Children's Hospital of Chicago
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Minnesota - Clinical and Translational Science Institute

Samples and Retentions

Study Population: Patients with cGVHD will be identified by their local physican and asked to participate in this research study. A total of 24 children will be asked to participate in this study. The parents of all of the 24 children will also be asked to participate and give us their feed-back on what it is like to cope with a child with cGVHD.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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