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
Visão geral do estudo
Status
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jin Wu, MD
- Número de telefone: 086-01088326002
- E-mail: wujin1996@126.com
Estude backup de contato
- Nome: Fanhao Nie
- Número de telefone: 086-18887323790
- E-mail: Niefh2003@163.com
Locais de estudo
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100044
- Recrutamento
- Peking University People's Hospital
-
Contato:
- Xiaohui Zhang, MD
- Número de telefone: 01088326666
- E-mail: wujin1996@126.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Coorte retrospectiva
Pacientes cuja primeira visita à nossa instituição e o término do acompanhamento ocorreram antes da abertura deste estudo contribuirão para a coorte retrospectiva.
|
|
Coorte prospectiva
Pacientes cuja primeira visita à nossa instituição ocorre após a abertura deste estudo contribuirá para a coorte em potencial.
|
|
Coorte retrospectiva/prospectiva
Pacientes cuja primeira visita à nossa instituição ocorreu antes da abertura deste estudo e cujo acompanhamento terá terminado após a abertura deste estudo contribuirá para a coorte ambispectiva.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
Prazo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
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.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with invasive fungal disease who have overall response at 1 year
Prazo: 1 year after diagnosis of invasive fungal disease
|
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.
|
1 year after diagnosis of invasive fungal disease
|
|
Cumulative incidence of proven or probable invasive fungal disease within 1 year after allo-HSCT
Prazo: From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
|
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.
|
From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
|
|
Number and percentage of participants with post-transplant complications within 5 years after allo-HSCT
Prazo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
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.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
|
Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0
Prazo: From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
|
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.
|
From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
|
|
Total length of hospital stay within 5 years after allo-HSCT, measured in inpatient days
Prazo: From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
|
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.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xiao-Hui Zhang, MD, Peking University Institute of Hematology, Peking University People's Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSCT-IFD2026
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .