NCT06013683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

July 23, 2023

Last Update Submit

October 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year)

    Evaluation of the morbidity rate over 2 years of Systemic Mastocytosis and its subtypes including Bone marrow mastocytosis (BMM), Indolent SM, Smoldering SM, Aggressive SM, SM with an associated hematologic neoplasm and Mast cell leukemia. (cases per 1,000 individuals per year)

    at 2 year

Secondary Outcomes (5)

  • Demographic characteristics of Systemic Mastocytosis

    at 2 year

  • Hematological characteristics of Systemic Mastocytosis

    at 2 year

  • Nonhematological characteristics of Systemic Mastocytosis

    at 2 year

  • Responses to therapy of Systemic Mastocytosis

    at 2 year

  • Survival Distribution of Systemic Mastocytosis

    at 2 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \. 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Mastocytosis, Systemic

Condition Hierarchy (Ancestors)

MastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMast Cell Activation DisordersImmune System Diseases

Study Officials

  • Suning Chen, Professor

    The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suning Chen, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Professor

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 28, 2023

Study Start

September 1, 2023

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations