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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00506233
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than or equal to 2 years
2. Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
3. If a prevalent case (defined as enrollment three or more months after chronic GVHD diagnosis), then subject must be within 2 years of stem cell infusion
4. Diagnosis of chronic GVHD meeting the diagnostic criteria of the diagnosis and staging group of the NIH consensus conference
5. Need for systemic treatment, defined as any medication or intervention delivered systemically, including extracorporeal photopheresis. If a patient only received topical or local therapy at diagnosis, but subsequently requires systemic treatment, they may be enrolled upon initiation of systemic therapy. (Note, these patients will be classified as incident or prevalent cases depending on time from chronic GVHD diagnosis, not start of systemic therapy)
6. Progression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
7. Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center at 3 and 6 months
8. Signed, informed consent and if applicable, child assent
Exclusion Criteria:
1. Inability to verbally communicate in English
2. Inability to comply with study procedures
3. Anticipated survival less than 6 months due to co-morbid disease or persistent malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00506233
Study Brief:
Protocol Section:
NCT00506233