Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00092235
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
120 Years
Study:
NCT00092235
Study Brief:
Protocol Section:
NCT00092235