Biomarker Panel Forecasts Chronic GVHD After Allo-HSCT
ClinicalTrials.gov Studies
Summary
NIH registered a single-center observational clinical study (NCT07539220) investigating a biomarker panel for forecasting chronic graft-versus-host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The discovery cohort enrolled 1000 consecutive patients retrospectively from January 2021 to June 2023, while a validation cohort of 500 recipients was enrolled from June 2023 to June 2024. Heparinized blood samples were collected at day +90 post-HSCT and analyzed using multiplex mass spectrometry with pooled plasma to compare proteomic profiles between patients with and without cGVHD.
“Heparinized blood samples were collected prospectively at day +90 after HSCT and the onset of manifestations in patients with cGVHD or at matched time points in controls.”
What changed
This document registers a new observational clinical study on ClinicalTrials.gov describing the methodology for developing a biomarker panel to forecast chronic graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. The study uses multiplex mass spectrometry proteomics to compare inflammatory cytokine and protein profiles between patients who develop cGVHD and controls at day +90 post-transplant.
Healthcare providers and clinical investigators involved in hematopoietic stem cell transplantation programs should note this as observational research development rather than a regulatory requirement. Transplant centers may wish to follow this research for potential future clinical applications of biomarker-guided cGVHD risk stratification, though no compliance obligations are imposed.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Establishment of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT
N/A NCT07539220 Kind: NA Apr 20, 2026
Abstract
This study is a single-center observational clinical study. Participants were enrolled as two cohorts of patients including discovery cohort and validation cohort. A total of consecutive 1000 patients receiving allo-HSCT in our center from 2021.01 to 2023.06 were retrospectively included as discovery cohort. A total of consecutive 500 recipients from 2023.06 to 2024.06 were retrospectively enrolled as validation cohort.
Heparinized blood samples were collected prospectively at day +90 after HSCT and the onset of manifestations in patients with cGVHD or at matched time points in controls. Patients in the validation cohort also had samples drawn at approximately day +90. We used multiplex mass spectrometry with pooled plasma for biomarker discovery in comparing proteomic profiles between patients with and without chronic GVHD.
Conditions: Chronic Graft-Versus-Host Disease
Interventions: Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum
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