Clinical trial NCT06013683: A Registry for Patients With Systemic Mastocytosis in China
Official title: Mastocvtosis Collaborative Network of China: A Registry for Patients With Systemic Mastocytosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Mastocytoses
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year)
timeFrame: at 2 year
Secondary outcomes:
measure: Demographic characteristics of Systemic Mastocytosis
timeFrame: at 2 year
measure: Hematological characteristics of Systemic Mastocytosis
timeFrame: at 2 year
measure: Nonhematological characteristics of Systemic Mastocytosis
timeFrame: at 2 year
measure: Responses to therapy of Systemic Mastocytosis
timeFrame: at 2 year
measure: Survival Distribution of Systemic Mastocytosis
timeFrame: at 2 year
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
name: Suning Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: