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

NCT07569055 | Recruiting DMC

• 1 other identifier: HSCT-IFD2026
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Fungal Disease; Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Invasive Fungal Disease; Prediction; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first

Secondary Outcomes (5)

• Proportion of participants with invasive fungal disease who have overall response at 1 year

  1 year after diagnosis of invasive fungal disease

• Cumulative incidence of proven or probable invasive fungal disease within 1 year after allo-HSCT

  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

  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

  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

  From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.

Study Arms (3)

Retrospective cohort

Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort.

Prospective cohort

Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort.

Retrospective/Prospective cohort

Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical 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
• Peking University People's Hospital: lead
• First Affiliated Hospital of Guangxi Medical University: collaborator
• The First Hospital of Jilin University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Xiao-Hui Zhang, MD

  Peking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Wu, MD

CONTACT

086-01088326002; wujin1996@126.com

Fanhao Nie

CONTACT

086-18887323790; Niefh2003@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 6, 2026
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 14, 2031
• Study Completion (Estimated): March 14, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-03

Locations

CN (1)