Actively Recruiting

Age: 1Year - 120Years
All Genders
NCT00092235

Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

Led by National Cancer Institute (NCI) · Updated on 2026-04-29

650

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Cancer Institute (NCI)

Lead Sponsor

E

Emory University, Department of Pediatrics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

Who Can Participate

Age: 1Year - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 1 year of age or older
  • Referred by primary transplant physician for evaluation of chronic graft-versus-host disease regardless of underlying diagnosis
  • Patient or legal representative able and willing to give consent
  • Control subjects must be 1 year or older
  • Control subjects have undergone allogeneic hematopoietic stem cell transplantation
  • Control subjects or their parent/guardian able and willing to give consent
Not Eligible

You will not qualify if you...

  • Significant medical condition or circumstance that may prevent tolerating, complying with, or completing the study
  • Life expectancy less than 3 months based on investigator assessment
  • Pregnant women
  • Control subjects with active graft-versus-host disease
  • Control subjects who received systemic immunosuppressant therapy for GVHD in the past 3 months
  • Control subjects who received therapy for malignancy in the past 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

N

Najla El Jurdi, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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