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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment Of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT
- ClinicalTrials.gov ID
- NCT07539220
- Acronym / sponsor ID
- IIT2025067
- Conditions
- Chronic Graft-Versus-Host Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Other | Other: Detection of Inflammatory Cytokine Levels in Peripheral Blood SerumThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Inflammatory Cytokine Levels in Peripheral Blood SerumThis 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 | Experimental Arm |
Primary outcome
To construct a diagnostic and predictive model for cGVHD
Time frame: day +90 after HSCT
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.
1 secondary outcome
To identify biomarkers associated with the prognosis of cGVHD
Time frame: day +90 after HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erlie Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To construct a diagnostic and predictive model for cGVHD (time frame: day +90 after HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.