NCT00092235 Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
| NCT ID | NCT00092235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Chronic Graft vs. Host Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2004-10-26 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2004-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival. * Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant (alloHSCT) in North America and about 50% of patients who are transplanted develop cGVHD. * Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties. There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation. Objectives: * To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD. * To prospectively identify clinical and biological prognostic markers in patients with cGVHD * To develop clinically relevant cGVHD grading scales * To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation * To identify potential clinical and biological markers of cGVHD activity * To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects * To identify potential patients for cGVHD treatment protocols at the NCI and NIH Eligibility: -Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis. Design: * Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic. * Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and/or rule-out other pathologic process (in adults only). * Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible
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
Contact & Investigator
Najla El Jurdi, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT00092235 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 120 Years, studying Chronic Graft vs. Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00092235 currently recruiting?
Yes, NCT00092235 is actively recruiting participants. Contact the research team at najla.eljurdi@nih.gov for enrollment information.
Where is the NCT00092235 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00092235 clinical trial?
NCT00092235 is sponsored by National Cancer Institute (NCI). The principal investigator is Najla El Jurdi, M.D. at National Cancer Institute (NCI). The trial plans to enroll 650 participants.