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

National Taiwan University

Status: Enrolling

Conditions: Bronchiolitis Obliterable Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07297303

202501048RIND

Details and patient eligibility

About

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

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

A hematopoietic stem cell transplantation cohort