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

1. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

6000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Rekrutierung
        • Peking University People's Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Retrospektive Kohorte
Patienten, deren erster Besuch in unserer Institution und die Beendigung der Nachuntersuchung beide vor der Eröffnung dieser Studie zu der retrospektiven Kohorte beitragen.
Prospektive Kohorte
Patienten, deren erster Besuch in unserer Institution nach der Eröffnung dieser Studie auftritt, werden zur prospektiven Kohorte beitragen.
Retrospektive/prospektive Kohorte
Patienten, deren erster Besuch in unserer Institution vor der Eröffnung dieser Studie stattfand und deren Follow-up nach der Eröffnung dieser Studie enden wird, werden zur Ambisspektivkohorte beitragen.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants with invasive fungal disease who have overall response at 1 year
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University People's Hospital

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. März 2025

Primärer Abschluss (Geschätzt)

14. März 2031

Studienabschluss (Geschätzt)

14. März 2031

Studienanmeldedaten

Zuerst eingereicht

18. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Mai 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Mai 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HSCT-IFD2026

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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