Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05923372
Collaborator
(none)
160
Enrollment
1
Location
12
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Evaluation of the Disability-Adjusted Life Year (DALY) on a Cohort of Patients With Indolent Systemic Mastocytosis (ISM)
    Actual Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with indolent systemic mastocytosis

    Patients with MSI, included in the CEREMAST registry and who have given their consent to participate

    Outcome Measures

    Primary Outcome Measures

    1. DALY [The outcome measure is collected once]

      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.

    Secondary Outcome Measures

    1. Quality of life based on the MC QOL scale [The outcome measure is collected once]

      The quality of life of the included patients will be described

    2. Frequency of symptoms [The outcome measure is collected once]

      The frequency of various symptoms of mast cell activation will also be described.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre de Référence des Mastocytoses, Service de Dermatologie, Hôpital Larrey, CHU Toulouse Toulouse Haute-Garonne France 31059

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT05923372
    Other Study ID Numbers:
    • RC31/23/0011
    • 2023-A00178-37
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    DALY
    Mastocytosis
    Quality of life
    Additional relevant MeSH terms:
    Mastocytosis
    Mastocytosis, Systemic

    Study Results

    No Results Posted as of Jun 28, 2023