Disease Burden Transition of Mucormycosis in Hematologic Malignancies Population Across Covid 19 Era: a Single-center Comparative Analysis From China

NCT06900114 | Completed

• 1 other identifier: QTJC2024056
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The project intends to carry out a retrospective study on the epidemiology, predisposing factors, clinical manifestations, diagnosis, treatment, prognosis and economic burden of mucormycosis in a Chinese single-center allogeneic hematopoietic stem cell transplantation population. The project was conducted at the Blood Diseases Hospital, Chinese Academy of Medical Sciences, which has rich experience in hematopoietic stem cell transplantation and has completed more than 3,000 cases of various types of HSCT, 400 allogeneic hematopoietic stem cell transplants per year, and routine bronchoscopy and application of guideline-recommended regimens for the treatment of mucormycosis. This study will objectively reflect the current management status of allogeneic hematopoietic stem cell transplantation combined with mucormycosis in Chinese transplant centers. Through systematic analysis of the changes in the management of mucormycosis in Chinese patients undergoing hematopoietic stem cell transplantation, to gain perspective into the impact of Covid19, diagnostic techniques, and new drugs on the incidence, diagnosis and treatment of mucormycosis . This will has a profound impact on optimizing the management strategies of mucormycosis in patients undergoing hematopoietic stem cell transplantation in the future.

Conditions

Mucormycosis; Hematologic Malignancies; COVID-19

Keywords

Mucormycosis; Hematologic Malignancies; COVID-19; China

Outcome Measures

Primary Outcomes (1)

• To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population

  Conduct a comparative analysis in 2015-2020 stage (Pre-Covid Era) and 2020-2024 stage (Covid Era). To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population from the aspects of incidence, mucorus species, types of mucormycosis, diagnostic techniques, treatment methods (surgical +drugs), pharmaceutical economics and prognosis between two stages. Objectively reflect the current management status of Mucormycosis in this population.

  2 YEARS

Secondary Outcomes (2)

• Analyze the possible causes of the epidemiology changing of mucormycosis: COVID19 influence, the advancement of diagnostic technology(NGS, respiratory endoscope intervention technique etc.) and other factors.

  2 YEARS

• Impact of treatment progress on disease prognosis and burden: the status of surgery changes

  2 YEARS

Study Arms (2)

Pre-Covid 19 group

Divide the patients into pre-covid 19 group(2015.01-2019.12) and covid 19 group(2020.1-2023.12) according to the time period.

Covid 19 group

Divide the patients into pre-covid 19 group(2015.01-2019.12) and covid 19 group(2020.1-2023.12) according to the time period.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with mucormycosis(proven or probable) in accordance with the 2008 EORTC/MSG criteria and Revised EORTC/MSGERC 2020 Criteria. Mucormycosis is a rare opportunistic fungal infection typically characterized by rapid progression, the main susceptible population is patients with diabetes and severe underlying diseases of immunocompromised patients with poor glycemic control (e.g., hematologic malignancies, hematopoietic stem cell transplantation, solid organ transplantation, etc.)

You may qualify if:

• Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation in the center from January 2015 to December 2023.
• Age≥18 years old.
• Patients who were diagnosed with mucormycosis(proven or probable) in accordance with the 2008 EORTC/MSG criteria and Revised EORTC/MSGERC 2020 Criteria.\[8\]\[9\].
• The patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent.

You may not qualify if:

• \. Patients with fungal infections other than mucormycosis were excluded.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Location

MeSH Terms

Conditions

Mucormycosis; Hematologic Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: March 28, 2025
• Study Start: February 8, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)