Status:
RECRUITING
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Emory University, Department of Pediatrics
Conditions:
Chronic Graft vs. Host Disease
Eligibility:
All Genders
1-120 years
Brief Summary
Background: * Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is ...
Detailed Description
Background: * Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- Patient or the patient's legal representative is able and willing to provide consent.
- EXCLUSION CRITERIA:
- 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
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
October 26 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00092235
Start Date
October 26 2004
Last Update
December 31 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892