Clinical Trial

Longitudinal Cohort Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Recruiting
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Summary
Invasive fungal disease (IFD) is one of the serious complications after hematopoietic stem cell transplantation (HSCT), characterized by high incidence and high mortality. According to the data from a multi-center study in China (CAESAR 2.0), even with the extensive use of antifungal active drugs for prevention, the cumulative incidence of IFD one year after HSCT still reached 6.3%, and the IFD-related mortality rate was 48.28%. In recent years, with the improvement of transplantation techniques, the application of new antifungal drugs and the optimization of diagnostic methods, the pathogen spectrum and clinical characteristics of IFD have undergone significant changes. Compared with ten years ago, the proportion of non-Aspergillus pathogens (such as Candida and Mucophora) has significantly increased, while the proportion of Aspergillus has relatively decreased. In addition, different types of invasive mycosis (such as invasive aspergillosis and invasive fusarium) show significant differences in clinical manifestations, onset time and prognosis. However, at present, large-scale prospective cohort studies on IFD after HSCT in China are still relatively scarce, and the diagnosis and treatment norms and prevention strategies in clinical practice still need to be further optimized. This study intends to conduct a multi-center retrospective and prospective combined longitudinal cohort study to comprehensively register the basic information, diagnosis, treatment and prognosis of IFD patients after HSCT, providing evidence-based medical basis for establishing new clinical diagnosis and treatment technologies and improving the long-term survival rate of patients.
Trial Details
NCT Number NCT07569055
Lead Sponsor Peking University People's Hospital
Collaborators: First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, Jining Medical University, Qianfoshan Hospital, Shandong Provincial Hospital, Shanxi Province Cancer Hospital, Shengjing Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Zhejiang University, The General Hospital of Northern Theater Command
Conditions Invasive Fungal Disease, Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Enrollment 6,000 participants
Start Date 2025-03-15
Primary Completion 2031-03-14 (estimated)
Study Completion 2031-03-14 (estimated)
Updated on ClinicalTrials.gov 2026-05-06