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RecruitingNCT07044076MenQOLUpdated Jun 29, 2025

Translation and Validation of the MQOL Self-questionnaire Into French for Assessing Quality of Life in Patients With Meningiomas

An observational study in Quality of Life and Meningioma, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Centre Hospitalier St Anne · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study summary

Meningiomas, which account for about 40% of primary central nervous system tumors, have significant psychological and social impacts, even without treatment. Their effect on quality of life is often underestimated and poorly documented. There is one validated questionnaire (MQOL) but it has not yet been translated into French. The project involves two phases: first, translating and linguistically validating the MQOL into French; second, scientifically validating the questionnaire with 50 meningioma patients using established scales (EQ-5D, Karnofsky, FACT-Br) to ensure its reliability and internal consistency.

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Conditions studied

  • Quality of Life
  • Meningioma

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03

In context

Meningioma

226 studies on the registry are indexed under Meningioma; 87 are open to participants now.

This study's planned enrollment of 50 is below the median of 132 across 56 observational studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

Centre Hospitalier St Anne is the lead sponsor of 99 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population will consist of three groups to ensure maximum heterogeneity:

  1. The study will be announced to all patients seen in consultation for meningioma at GHU Paris - Sainte-Anne (France).
  2. All patients who are members of the AMAVEA association will be notified of the study by email.
  3. Any patient referred by partner teams following a call for participation within the Neuro-Oncology Club and the Skull Base Club of the French Neurosurgery Society, recruited under the same procedure as the AMAVEA association.

Inclusion criteria

  • Patient aged 18 years or older
  • Diagnosis of intracranial meningioma confirmed by imaging or surgery

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women (Article L1121-5)
  • Patients deprived of liberty by judicial or administrative decision, as well as individuals undergoing psychiatric care (Article L1121-6)
  • Patients not fluent in French or with poor understanding of the language
  • Inability to refuse participation in the study
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • OtherQuality of life

    The four questionnaires (MQOL, EQ-5D, Karnofsky, and FACT-Br) will be sent to patients online using the secure online platform Redcap.

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What researchers measure

Primary outcomes

  1. meningioma-specific quality-of-life questionnaire

    The meningioma-specific quality-of-life questionnaire (MQOL) is an self-administered questionnaires and a validated tool used in practice in English, specifically applicable to patients with meningiomas, and was developed by a Canadian team (Baba A, Saha A, McCradden MD, Boparai K, Zhang S, Pirouzmand F, Edelstein K, Zadeh G, Cusimano MD. Development and validation of a patient-centered, meningioma-specific quality-of-life questionnaire. J Neurosurg. 2021 May 14;135(6):1685-1694. doi: 10.3171/2020.11.JNS201761. PMID: 33990085.) This project will involve applying the MQOL to a population of 50 patients and comparing it with self-administered questionnaires already validated in French practice (FACT-Br, Karnofsky, and EQ-5D). The purpose of all these questionnaires is to assess quality of life in patients. The EQ-5D and Karnofsky evaluate it in a general manner, while the FACT-Br is used in an oncological context.

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • GHU Paris -Psychiatrie & Neurosciences
    Paris, 15014, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07044076
Lead sponsor
Centre Hospitalier St Anne
Responsible party
Sponsor
First posted
Jun 29, 2025
Start date
Jun 13, 2025
Primary completion
Jul 13, 2025 (estimated)
Completion
Dec 12, 2025 (estimated)
Last update
Jun 29, 2025

Study contacts

Viviane AWASSI
Contact
v.awassi@ghu-paris.fr
01.45.65.84.86
Benoît HUDELIST, Dr
Contact
benoit.hudelist@ghu-paris.fr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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