AzTrials
AzTrials

Systemic MastocytosesNCT06013683

A Registry for Patients With Systemic Mastocytosis in China

An observational study of Systemic Mastocytoses, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Systemic Mastocytoses
How many people
150 participants
Where
1 siteChina
Study dates
1 Sep 2023to 31 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Suning Chen, Professor contact

+86-13814881746

chensuning@sina.com

China1 site, 1 recruiting

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

    Suzhou, Jiangsu, 215006

    Suning Chen, +8613814881746, chensuning@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Medical subject headings
Mastocytosis, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: at 2 year

Secondary outcomes (5)

  1. Demographic characteristics of Systemic Mastocytosis

    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]);

    Measured: at 2 year

  2. Hematological characteristics of Systemic Mastocytosis

    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(%).

    Measured: at 2 year

  3. Nonhematological characteristics of Systemic Mastocytosis

    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 (%).

    Measured: at 2 year

  4. Responses to therapy of Systemic Mastocytosis

    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(%).

    Measured: at 2 year

  5. Survival Distribution of Systemic Mastocytosis

    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.

    Measured: at 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06013683
Sponsor's protocol ID
SZ-SM01
Status last verified
Oct 2023
First submitted
23 Jul 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Mastocytoses, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suning Chen, Professor (+86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year) (time frame: at 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06013683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in