Chronic Graft-Versus-Host DiseaseNCT07539220
Establishment of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT
A study testing Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum in people with Chronic Graft-Versus-Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft-Versus-Host Disease
- What is being tested?
- Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Chronic Graft-Versus-Host Disease
- Being tested
- Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Inflammatory Cytokine Levels in Peripheral Blood SerumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Detection of Inflammatory Cytokine Levels in Peripheral Blood Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day +90 after HSCT
Secondary outcomes (1)
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.
Measured: day +90 after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539220
- Sponsor's protocol ID
- IIT2025067
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No