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

1 maja 2026 zaktualizowane przez: Xiao Hui Zhang, Peking University People's Hospital

Retrospective and Prospective Longitudinal Observational Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

6000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100044
        • Rekrutacyjny
        • Peking University People's Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

Since January 1, 2014, patients who underwent allo-HSCT at Peking University People's Hospital and other assistance centers.

Exclusion Criteria:

  1. For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
  2. Patients deemed unsuitable for the study by the researchers.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Retrospektywna kohorta
Pacjenci, których pierwsza wizyta w naszej instytucji i zakończenie obserwacji wystąpiły przed otwarciem tego badania, przyczynią się do kohorty retrospektywnej.
Potencjalna kohorta
Pacjenci, których pierwsza wizyta w naszej instytucji występuje po otwarciu tego badania, przyczynią się do potencjalnej grupy.
Kohorta retrospektywna/prospektywna
Pacjenci, których pierwsza wizyta w naszej instytucji wystąpiła przed otwarciem tego badania i których obserwacja zakończy się po otwarciu tego badania, przyczynią się do zakłóceń.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants with invasive fungal disease who have overall response at 1 year
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking University People's Hospital

Współpracownicy

Shanxi Province Cancer Hospital
Shengjing Hospital
Shandong Provincial Hospital
The First Hospital of Jilin University
Qianfoshan Hospital
Zhejiang University
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital of Harbin Medical University
Jining Medical University
First Affiliated Hospital of Guangxi Medical University
The General Hospital of Northern Theater Command

Śledczy

  • Główny śledczy: Xiao-Hui Zhang, MD, Peking University Institute of Hematology, Peking University People's Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 marca 2025

Zakończenie podstawowe (Szacowany)

14 marca 2031

Ukończenie studiów (Szacowany)

14 marca 2031

Daty rejestracji na studia

Pierwszy przesłany

18 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 maja 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 maja 2026

Ostatnia weryfikacja

1 marca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HSCT-IFD2026

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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