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Natural History Study of Chronic Graft-Versus-Host Disease

This observational study aims to better understand chronic graft-versus-host disease (cGVHD), a condition that can occur after a stem cell transplant. Researchers want to find markers that predict how cGVHD will progress and to learn more about how cGVHD affects the body. They are also looking for ways to improve our understanding of how cGVHD impacts the anti-tumor effect of the transplant. This study is open to patients aged 1 year and older who have been referred for cGVHD evaluation. There are no specific interventions or treatments being tested in this study. The study is currently ongoing and plans to include about 650 participants.

Study design
This is an observational study, meaning no specific treatments are given. It aims to enroll about 650 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will look at markers for prognosis up to 2 years and 3 months after you join. Other aspects of the study are ongoing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00092235

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

Recruiting
Not specifiedAges 1+Observational
National Cancer Institute (NCI)
~650 participants
Updated 2026-09-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To prospectively identify candidate markers for clinical and biological prognostic factors in patients with cGVHD and develop a prognostic model
Measured over 2 years + 3 months after protocol entry
+5 more outcomes measured

Conditions

Chronic Graft vs. Host Disease

Explore related trials

Allogeneic Hematopoietic Stem Cell TransplantationChronic Graft Versus Host Disease

NCT00092235

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Najla El Jurdi, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Najla El Jurdi, M.D.
[email protected]
(240) 992-4033
Email the study team

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Eligibility criteria

Inclusion

Age 1 and older
Patient has undergone Allo-HSCT
Patient or the patient's parent/guardian is able and willing to provide consent

Exclusion

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

What this trial measures

  • To prospectively identify candidate markers for clinical and biological prognostic factors in patients with cGVHD and develop a prognostic model2 years + 3 months after protocol entry

    Patient evaluations resulting in collection of data via several medical specialties; data will be examined individually and against clinical outcomes.

  • To improve our current understanding of the biology of cGVHD-associated graft-versus-tumor effects (GVT).ongoing

    Studying mechanisms of how cGVHD exerts its anti-cancer effects via laboratory analysis.

  • To identify potential clinical and biological markers of cGVHD activityongoing

    Assessment of risk and outcome as related to molecular markers of pathogenesis and/or stage of disease.

  • To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentationongoing

    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.

  • To establish a multidisciplinary clinic infrastructure for study of pathogenesis and natural history of cGVHDongoing

    Assessment of clinical and biological characteristics of cGVHD.

  • To develop clinically relevant cGVHD grading scalesongoing

    Develop appropriate staging as a tool for measuring responses or outcomes in clinical studies through prospective collection and analysis of data.