Longitudinal Cohort Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Retrospective and Prospective Longitudinal Observational Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Panoramica dello studio
Stato
Descrizione dettagliata
Invasive fungal disease refers to a severe infection caused by fungi invading human tissues, blood or body fluids, mainly affecting people with weakened immune systems. Under the background of HSCT, due to the transplantation recipients undergoing high-dose chemotherapy pretreatment, graft-versus-host disease (GVHD), and the use of immunosuppressants, the immune function of the body is severely impaired, and the risk of IFD occurrence significantly increases. The clinical manifestations of IFD after HSCT are diverse, which can involve multiple organs and systems such as the lungs, blood, central nervous system, and skin. It is difficult to diagnose, challenging to treat, and has a poor prognosis, seriously affecting the long-term survival and quality of life of transplant patients.
In recent years, the epidemiological characteristics of IFD after HSCT have undergone significant changes. According to the CAESAR 2.0 study, among 2015 Chinese patients who received allo-HSCT, the cumulative one-year incidence of IFD (proven + probable) was 6.3%. It is worth noting that compared with the CAESAR study ten years ago, the pathogen spectrum has undergone a significant transformation, which is closely related to the evolution of antifungal prevention strategies - ten years ago, fluconazole was mainly used for prevention, while currently about three quarters of patients use antifungal active drugs such as voliconazole or posaconazole. Although this shift in preventive strategies has reduced the occurrence of aspergillosis, it may increase the risk of infection from drug-resistant pathogens such as Mucor.
IFD after HSCT remains a major clinical challenge affecting the prognosis of patients. The current research has the following deficiencies: (1) There is still a lack of multi-center, large-sample prospective cohort studies in China; (2) The dynamic changes in the pathogen spectrum and clinical characteristics of IFD require continuous monitoring. (3) The diagnosis and treatment strategies and prognostic factors of different types of IFD need in-depth research. Based on the above background, this study intends to establish a longitudinal observational cohort that combines retrospective and prospective approaches to systematically evaluate the epidemiological characteristics, treatment strategies, and short-term and long-term outcomes of IFD patients after HSCT.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jin Wu, MD
- Numero di telefono: 086-01088326002
- Email: wujin1996@126.com
Backup dei contatti dello studio
- Nome: Fanhao Nie
- Numero di telefono: 086-18887323790
- Email: Niefh2003@163.com
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100044
- Reclutamento
- Peking University People's Hospital
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Contatto:
- Xiaohui Zhang, MD
- Numero di telefono: 01088326666
- Email: wujin1996@126.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
Since January 1, 2014, patients who underwent allo-HSCT at Peking University People's Hospital and other assistance centers.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Coorte retrospettiva
I pazienti la cui prima visita alla nostra istituzione e la risoluzione del follow-up si sono verificate entrambi prima dell'apertura di questo studio contribuiranno alla coorte retrospettiva.
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Coorte potenziale
I pazienti la cui prima visita alla nostra istituzione si verifica dopo l'apertura di questo studio contribuiranno alla coorte prospettica.
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Coorte retrospettiva/prospettica
I pazienti la cui prima visita alla nostra istituzione si è verificata prima dell'apertura di questo studio e il cui follow-up terminerà dopo l'apertura di questo studio contribuirà alla coorte ambispettiva.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
Lasso di tempo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
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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.
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From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Proportion of participants with invasive fungal disease who have overall response at 1 year
Lasso di tempo: 1 year after diagnosis of invasive fungal disease
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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.
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1 year after diagnosis of invasive fungal disease
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Cumulative incidence of proven or probable invasive fungal disease within 1 year after allo-HSCT
Lasso di tempo: From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
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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.
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From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
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Number and percentage of participants with post-transplant complications within 5 years after allo-HSCT
Lasso di tempo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
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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.
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From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
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Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0
Lasso di tempo: From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
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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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From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
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Total length of hospital stay within 5 years after allo-HSCT, measured in inpatient days
Lasso di tempo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
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Total length of hospital stay is defined as the cumulative number of inpatient days recorded for each participant after allogeneic hematopoietic stem cell transplantation and before death, last contact, or 5 years after transplantation, whichever occurs first.
The outcome will be summarized as inpatient days per participant using descriptive statistics.
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From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Xiao-Hui Zhang, MD, Peking University Institute of Hematology, Peking University People's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HSCT-IFD2026
Informazioni su farmaci e dispositivi, documenti di studio
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