NCT03632811

Brief Summary

Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015. The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

7 days

First QC Date

August 13, 2018

Last Update Submit

July 15, 2019

Conditions

Cutaneous MastocytosisIndolent Systemic Mastocytosis

Keywords

cutaneous mastocytosisindolent systemic mastocytosisquality of life questionnaire in mastocytosis patient

Outcome Measures

Primary Outcomes (4)

  • The understanding of aspects of the questionnaire Mc-QoL

    The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient: \- the instructions

    1 day

  • The understanding of aspects of the questionnaire Mc-QoL

    The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : \- the questions (items) and the proposed answers

    1 day

  • The understanding of aspects of the questionnaire Mc-QoL

    The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : \- the layout of the questionnaire

    1 day

  • The understanding of aspects of the questionnaire Mc-QoL

    The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : \- the language (words) used, if it is simple and appropriate

    1 day

Interventions

A structured interview with every patientOTHER

The comprehension test will be done through structured interviews in which the principal investigator will ask if the patient has had difficulty understanding the recommendations and questions, will check the interpretation of all items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who has indolent cutaneous or systemic mastocytosis

You may qualify if:

  • Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at CEREMAST, Toulouse
  • Patient having given his agreement of non-opposition

You may not qualify if:

  • Minor patient
  • Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis
  • Patient with no mast cell pathology
  • French non-native patient
  • Patient in detention or under guardianship
  • Patient not affiliated with Social Security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Mastocytosis, CutaneousMastocytosis, Systemic

Condition Hierarchy (Ancestors)

MastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesMast Cell Activation DisordersImmune System Diseases

Study Officials

  • Cristina Bulai Livideanu, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

November 14, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)