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

N/ANot Yet RecruitingNCT07539220

Institute of Hematology & Blood Diseases Hospital, China1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Chronic Graft-Versus-Host Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To construct a diagnostic and predictive model for cGVHD

By analyzing plasma samples from cGVHD patients using mass spectrometry (MS) technology, the aim is to identify biomarkers associated with cGVHD. Additionally, the model will integrate clinical information (such as transplant type, HLA matching, aGVHD history, etc.) to develop a comprehensive predictive model that can accurately diagnose cGVHD and predict disease -severity. This model will help improve early-stage recognition of cGVHD, especially in cases where symptoms are non-specific or difficult to detect and provide clinical decision support.

Time frame: day +90 after HSCT

Secondary Outcomes

To identify biomarkers associated with the prognosis of cGVHD

Through mass spectrometry analysis, this study will explore the relationship between biomarkers in plasma samples and the treatment response, and severity of cGVHD patients. The goal is to identify biomarkers closely linked to cGVHD prognosis, providing more accurate risk assessment and long-term prognostic prediction tools for patients.