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NCT07539220
NA

Establishment of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

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.

Official title: Establishment Of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

OTHER

Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum

This study is expected to develop a comprehensive predictive model based on plasma mass spectrometry data and clinical information, significantly improving the accuracy of early cGVHD prediction. By conducting in-depth analysis of plasma samples from cGVHD patients using mass spectrometry (MS) technology and integrating clinical data, the goal is to identify a set of biomarkers that can accurately diagnose, predict disease progression, and assess prognosis. This approach aims to develop a clinically actionable tool for cGVHD diagnosis and prediction, enabling early detection and precise intervention. The model will provide clinicians with more precise diagnostic tools and treatment decision support, facilitating early detection and targeted treatment of cGVHD. Additionally, the findings of this study will offer new data to support further biological research on cGVHD mechanisms and provide a theoretical basis for future personalized medicine approaches.