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

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

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.

Inclusion Criteria:

1. Patients with hematological disease survived more than 3 months after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
2. Over 18 years old.
3. Written informed consent or a waiver by the Ethics Committee (EC) at the site.
4. HIV negative, HBV, HCV negative.

Exclusion Criteria:

1. Previous autologous or allogeneic stem cell transplantation before enrollment.
2. Suffering from mental illness or other conditions and not being able to cooperate with research treatment and monitoring requirements.
3. Patients with other special conditions who were assessed as unqualified by the researchers.