Evaluation of the DALY on a Cohort of Patients With Indolent Systemic Mastocytosis (DALY-MAST)

July 10, 2023 updated by: University Hospital, Toulouse

Evaluation of the Disability-Adjusted Life Year (DALY) on a Cohort of Patients With Indolent Systemic Mastocytosis (ISM)

Mastocytosis is a group of pathologies characterized by the accumulation and/or clonal proliferation of abnormal mast cells in various organs. The impact of mastocytosis on health, quality of life, the psychoaffective sphere and on professional life constitutes the burden of this disease. The DALY is the disability-adjusted life expectancy, which takes into account the life expectancy and the number of years "lost" due to illness, disability or early death. Due to the major impact of the disease this study evaluates the DALY in indolent mastocytosis patients

Study Overview

Status

Recruiting

Conditions

Detailed Description

Mastocytosis is a group of pathologies characterized by the accumulation and/or clonal proliferation of abnormal mast cells in various organs. Mastocytosis is a rare disease with an estimated prevalence of between 1/20,000 and 1/40,000. The impact of mastocytosis on health, quality of life, the psychoaffective sphere and on professional life constitutes the burden of this disease. This is probably important but very little studied so far. The DALY is the disability-adjusted life expectancy. It is calculated by subtracting from life expectancy the number of years "lost" due to illness, disability or early death.

Ignorance of the disease and diagnostic error cause significant distress in patients. In our clinical experience, the impact of the disease on the personal, social, and professional life of our patients is major. It therefore seems important to better specify the impact on the quality of life and the costs of this pathology. The main objective of this study is to evaluate the DALY in indolent mastocytosis patients from the CEREMAST reference center of the Toulouse University Hospital.

Study Type

Observational

Enrollment (Estimated)

160

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

  • France
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • Centre de Référence des Mastocytoses, Service de Dermatologie, Hôpital Larrey, CHU Toulouse
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with MSI, included in the CEREMAST register and who have given their consent to participate

Description

Inclusion Criteria:

  • Having expressed their non opposition to participate in this study
  • Diagnosed with indolent mastocytosis and cared for in the CEREMAST reference center in Toulouse

Exclusion Criteria:

  • Patient with a form of mastocytosis other than MSI
  • Patient under legal protection, guardianship or curatorship

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

Cohorts and Interventions

Group / Cohort
Patients with indolent systemic mastocytosis (IMS)
Patients with IMS, included in the CEREMAST registry and who have given their consent to participate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DALY
Time Frame: Day 1
DALY (Disability Adjusted Life Year): Its calculation consists of subtracting from life expectancy the number of years "lost" due to illness, disability or early death.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life based on the MC QOL scale
Time Frame: Day 1
The quality of life of the included patients will be described with the The Mastocytosis Quality of Life Questionnaire (MC-QoL) which has scores from 0 to 100, where higher scores indicate higher health-related quality-of-life impairment
Day 1
Frequency of symptoms
Time Frame: Day 1
The frequency of various symptoms of mast cell activation will also be described.
Day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Cristina BULAI LIVIDEANU, MD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0011
  • 2023-A00178-37 (Other Identifier: N°ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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