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

NCT07539220 | Not Yet Recruiting

• 1 other identifier: IIT2025067
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To identify biomarkers associated with the prognosis of cGVHD

  day +90 after HSCT

Study Arms (1)

Experimental Arm

OTHER

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

Interventions

Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum OTHER

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Erlie Jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Xiaoyu Zhang

CONTACT

+86-18202579691; zhangxiaoyu@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share