A Registry for Patients With Systemic Mastocytosis in China

October 7, 2023 updated by: Chen Suning, The First Affiliated Hospital of Soochow University

Mastocvtosis Collaborative Network of China: A Registry for Patients With Systemic Mastocytosis

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year)
Time Frame: at 2 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristics of Systemic Mastocytosis
Time Frame: at 2 year
  1. The median age of Systemic Mastocytosis patients (year-old);
  2. The sex distribution of Systemic Mastocytosis patients (M/F ratio[0-1]);
  3. The ECOG score of Systemic Mastocytosis patients (score[0-5]);
  4. The geographic distribution of Systemic Mastocytosis patients (% per province[0-100]);
at 2 year
Hematological characteristics of Systemic Mastocytosis
Time Frame: at 2 year
  1. The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%);
  2. The proliferative degree in sections of BM (%);
  3. The ratio of mast cells in BM smear and FCM (%);
  4. The ratio of expression of CD25, CD2, and CD30 in FCM (%);
  5. The serum tryptase level(%).
at 2 year
Nonhematological characteristics of Systemic Mastocytosis
Time Frame: at 2 year
  1. The incidence of extramedullary organ infiltration including skin, bone and other organs (%);
  2. The incidence of enlarged liver (%);
  3. The incidence of enlarged spleen (%);
  4. The incidence of enlarged lymphnodes (%);
  5. The incidence of hypoproteinemia and loss weight (%).
at 2 year
Responses to therapy of Systemic Mastocytosis
Time Frame: at 2 year
  1. The rate of eligible complete remission (CR) patients(%);
  2. The rate of eligible partial remission (PR) patients(%);
  3. The rate of eligible clincal improvement (CI) patients(%);
  4. The rate of eligible stable disease (SD) patients(%);
  5. The rate of eligible progressive disease (PD) patients(%);
  6. The rate of eligible loss of reponse (LOR) patients(%).
at 2 year
Survival Distribution of Systemic Mastocytosis
Time Frame: at 2 year
  1. Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death;
  2. Event-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.
at 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Suning Chen, professor, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ-SM01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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