An observational study in Chronic Graft vs. Host Disease, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 1 Year to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by National Cancer Institute (NCI) · Observational
Background:
Objectives:
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:
Background:
Objectives:
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:
National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be selected via referrals or from patients who were on companion clinical protocols at the NIH.
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
EXCLUSION CRITERIA:
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.
Inclusion Criteria for control subjects without cGVHD:
Exclusion Criteria for control subjects without cGVHD:
Patients who have undergone an allogeneic stem cell transplant and are diagnosed with cGVHD
Pediatric patients who have undergone an allogeneic stem cell transplant and are diagnosed with cGVHD
Patients who have undergone an allogeneic stem cell transplant and choose to submit biopsy, blood and urine samples only
Patients who have undergone an allogeneic stem cell transplant and are not diagnosed with cGVHD
To prospectively identify candidate markers for clinical and biological prognostic factors in patients with cGVHD and develop a prognostic model
Patient evaluations resulting in collection of data via several medical specialties; data will be examined individually and against clinical outcomes.
Time frame: 2 years + 3 months after protocol entry
To improve our current understanding of the biology of cGVHD-associated graft-versus-tumor effects (GVT).
Studying mechanisms of how cGVHD exerts its anti-cancer effects via laboratory analysis.
Time frame: ongoing
To identify potential clinical and biological markers of cGVHD activity
Assessment of risk and outcome as related to molecular markers of pathogenesis and/or stage of disease.
Time frame: ongoing
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation
Through collection of data via several medical specialties, assess the weight of specific clinical and biological characteristics and disease severity scales for predicting major clinical outcomes.
Time frame: ongoing
To establish a multidisciplinary clinic infrastructure for study of pathogenesis and natural history of cGVHD
Assessment of clinical and biological characteristics of cGVHD.
Time frame: ongoing
To develop clinically relevant cGVHD grading scales
Develop appropriate staging as a tool for measuring responses or outcomes in clinical studies through prospective collection and analysis of data.
Time frame: ongoing
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Sap, Icf
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National Cancer Institute (NCI)