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Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients

NCT ID: NCT07297303

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-12-31

Brief Summary

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Prospective observational study on the clinical characteristics of pulmonary graft-versus-host disease in patients after hematopoietic stem cell transplantation.

Detailed Description

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In patients undergoing hematopoietic stem cell transplantation (HSCT), pulmonary complications include both infectious and non-infectious conditions. Among these, bronchiolitis obliterans syndrome(BOS) represents a severe manifestation of pulmonary graft-versus-host disease. BOS typically develops within two years after HSCT, with a median time to diagnosis ranging from 6 months to 1 year. However, it may occur at any time between 50 days and 10 years post-transplantation. During the early course of the disease, many patients are asymptomatic; progressive dyspnea and cough subsequently develop, usually over weeks to months. Potential risk factors include chronic graft-versus-host disease, older age, impaired pre-transplant pulmonary function, and early respiratory infections.

The current diagnostic criteria for BOS are still based on the recommendations of the 2014 National Institutes of Health Consensus on chronic graft-versus-host disease. Treatment for BOS remains complex and is supported by limited evidence. In Taiwan, local data on pulmonary complications-particularly BOS-remain insufficient.

We aim to establish a prospective cohort study enrolling approximately 600 participants to analyze the epidemiology, clinical manifestations, pulmonary function changes (including impulse oscillometry), imaging findings, and biomarker alterations associated with pulmonary graft-versus-host disease in Taiwanese HSCT recipients.

Conditions

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Bronchiolitis Obliterable Syndrome

Keywords

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hematopoietic stem cell transplantation GvHD Obstructive airway disease Pulmonary rehabilitation Cardiopulmonary exercise test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A hematopoietic stem cell transplantation cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age\>18
2. Will Receive first time Allo-HSCT patients

Exclusion Criteria

1. Respiratory failure
2. Hemodynamic unstable
3. Pneumothorax or bronchial fistula
4. Acute coronary syndrome in recent 1 month
5. The patient couldn't walk longer than 20 m
6. Severe lower-limb arthropathy
7. The patient couldn't cooperate well
8. Need all-day oxygen supplement
9. The patient received lung transplantation before
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ting-Yu Liao

Role: CONTACT

Phone: +886 2312-3456

Email: [email protected]

Zong-Han Yao

Role: CONTACT

Phone: +886 2312-3456

Email: [email protected]

Other Identifiers

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202501048RIND

Identifier Type: -

Identifier Source: org_study_id