MedDataX Logo

Assessment of Burden Disease in Patients With Mast Cell Disorders

NCT ID: NCT04615663

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-28

Study Completion Date

2022-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". It seems possible by a longitudinal study (patient follow-up over 1 year).

Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. The release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. These symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc.

In mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs.

According to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mastocytosis Cutaneous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

face-to-face patients

During this visit, the investigator will complete the SMI score.

Score SMI

Intervention Type BEHAVIORAL

the investigator will complete the SMI score

Email patients

this visit at M0 + 7d will correspond to the emailing of the Mc\_QoL and Burden\_MCD questionnaires completed by the patient.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Score SMI

the investigator will complete the SMI score

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patient (\> 18 years old) with confirmed mast cell disorder according to international criteria
* Patient affiliated to social security regime

Exclusion Criteria

* Patient under legal protection (guardianship, curators or court order)
* Patient does not speak French
Minimum Eligible Age

18 Months

Maximum Eligible Age

65 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LIVIDEANU Cristina, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cristina BULAI LIVIDEANU

Toulouse, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

LIVIDEANU Cristina, MD

Role: CONTACT

[email protected]
0567778135 ext. +33

NEGRETTO Mathilde

Role: CONTACT

[email protected]
05 67 77 81 68 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cristina BULAI LIVIDEANU, MD

Role: primary

[email protected]
567778135 ext. +33

Isabelle OLIVIER, PhD

Role: backup

[email protected]
0561777051 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC31/19/0354

Identifier Type: -

Identifier Source: org_study_id