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Trial Title:
A Registry for Patients With Systemic Mastocytosis in China
NCT ID:
NCT06013683
Condition:
Systemic Mastocytoses
Conditions: Official terms:
Mastocytosis
Mastocytosis, Systemic
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
The Registry for Patients With Systemic Mastocytosis in China is a voluntary,
observational database that will capture demographic, socioeconomic, and disease
information with systemic mastocytosis. No experimental intervention is involved.
Detailed description:
Systemic Mastocytosis (SM) is an extremely rare and heterogeneous spectrum of diseases
characterized by the buildup of genetically altered mast cells in bone marrow sections
and/or other extracutaneous organ(s). SM has not been given enough attention in China at
present, and the epidemiological data in China are not clear. To understand the
epidemiological characteristics and distribution patterns of SM patients in China. To
establish a China-wide database platform for registering SM patients and to develop
uniform registration standards and processes; to register SM patients who meet the
enrollment criteria nationwide through a multicenter collaborative approach and to
collect information on their baseline data, clinical manifestations, laboratory tests,
treatment regimens, and follow-up results; to perform quality control and data cleansing
on the information collected in the registration database, as well as to perform
descriptive and inferential statistical analyses.
Criteria for eligibility:
Study pop:
Patients with a diagnosis of systemic mastocytosis according to World Health Organization
(WHO) classification, including subtypes of SM, who is willing and able to provide
written online informed consent.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Any patient with a diagnosis of systemic mastocytosis according to World Health
Organization (WHO) classification, including subtypes of SM, who is willing and able
to provide written online informed consent.
Exclusion Criteria:
None
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen
Phone:
+8613814881746
Email:
chensuning@sina.com
Start date:
September 1, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06013683
