Understanding chronic graft-versus-host disease outcomes
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
This study is trying to understand how different factors affect the outcomes for patients with chronic graft-versus-host disease after a stem cell transplant, to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 1 Year to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00092235 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the clinical and biological factors that influence outcomes in patients with chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation. It will establish a multidisciplinary clinic to study the pathogenesis and natural history of cGVHD, identify prognostic markers, and develop grading scales for clinical relevance. The study will also explore the biological characteristics of cGVHD and their relationship with clinical presentations, ultimately aiming to improve treatment strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 1 and older who have been referred for evaluation of chronic graft-versus-host disease.
Not a fit: Patients with significant medical conditions affecting their ability to participate or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of chronic graft-versus-host disease, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in understanding cGVHD, but this approach focuses on a comprehensive, multidisciplinary evaluation, making it a novel effort.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 1. Any patient age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independently of age or underlying diagnosis 2. Patient or the patient's legal representative is able and willing to provide consent. EXCLUSION CRITERIA: 1. Significant medical condition or any other significant circumstance that could in the PIs assessment affect the patient's ability to tolerate, comply, or complete the study 2. Patients who in the PIs assessment have a life expectancy \<3 months. Note: Because it is not always possible to make a clear clinical distinction between acute and chronic GVHD, patients with acute GVHD are not a-priori excluded until the possibility of chronic GVHD is reliably excluded on the basis of the clinical assessments in the cGVHD clinic. 3. Pregnant women are excluded from this study because multiple tests would need to be excluded for safety of the patient and the fetus. Inclusion Criteria for control subjects without cGVHD: * Age 1 and older * Patient has undergone Allo-HSCT * Patient or the patient's parent/guardian is able and willing to provide consent Exclusion Criteria for control subjects without cGVHD: * Active GVHD * In the previous three months have received systemic immunosuppressant therapy for the treatment of GVHD * In the previous three months have received therapy for malignancy
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Najla El Jurdi, M.D. — National Cancer Institute (NCI)
- Study coordinator: Najla El Jurdi, M.D.
- Email: najla.eljurdi@nih.gov
- Phone: (240) 992-4033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.