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.
None
For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
Patients deemed unsuitable for the study by the researchers.
Study population: Patients who underwent allo-HSCT at Peking University People's Hospital and other assistance centers since January 1, 2014. Outcome Assessment: Patients were followed up for the development of invasive fungal disease (IFD) after transplantation.
Cohort
Other
Not listed
Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
Overall survival is defined as the time from the date of allogeneic hematopoietic stem cell transplantation to death from any cause. Participants without documented death will be censored at the date of last contact or at 5 years after transplantation, whichever occurs first. Overall survival probabilities at 1, 3, and 5 years after transplantation will be estimated using the Kaplan-Meier method.
Proportion of participants with invasive fungal disease who have overall response at 1 year
Overall response of invasive fungal disease is defined as complete response or partial response at 1 year after diagnosis of invasive fungal disease. Response will be assessed according to the Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria for treatment response in invasive fungal diseases. Participants who die before the 1-year assessment or do not meet complete or partial response criteria will be classified as not having overall response. The outcome will be summarized as the number and percentage of participants with complete or partial response.
Cumulative incidence of proven or probable invasive fungal disease within 1 year after allo-HSCT
Invasive fungal disease is defined as the first episode of proven or probable invasive fungal disease after allo-HSCT according to protocol-defined diagnostic criteria based on EORTC/MSGERC definitions. Death before invasive fungal disease will be treated as a competing event. Participants who do not develop invasive fungal disease and do not die will be censored at the date of last contact or at 1 year after allo-HSCT, whichever occurs first. The cumulative incidence function will be used to estimate the incidence of invasive fungal disease.
Number and percentage of participants with post-transplant complications within 5 years after allo-HSCT
Post-transplant complications include acute graft-versus-host disease, chronic graft-versus-host disease, cytomegalovirus infection or reactivation, Epstein-Barr virus infection or reactivation, bacterial bloodstream infection, organ dysfunction, relapse of the underlying hematologic disease, graft failure, intensive care unit admission. The outcome will be summarized as the number and percentage of participants with at least one post-transplant complication and by complication category.
Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0
Treatment-related adverse events are adverse events considered related to systemic antifungal therapy. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The outcome will be summarized as the number and percentage of participants with at least one treatment-related adverse event. Grade 3 or higher adverse events and serious adverse events will be summarized separately.
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Peking University People's Hospital
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
The First Hospital of Jilin University
Collaborator
Jining Medical University
Collaborator
Qianfoshan Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Zhejiang University
Collaborator
The General Hospital of Northern Theater Command
Collaborator
