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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Graft-Versus-Host Disease
• Intervention / Treatment: Other: Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erlie Jiang; Phone Number: +86-15122538106; Email: jiangerlie@ihcams.ac.cn
• Study Contact Backup: Name: Xiaoyu Zhang; Phone Number: +86-18202579691; Email: zhangxiaoyu@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Experimental Arm; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day +90 after HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day +90 after HSCT

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: IIT2025067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No