Intracranial MeningiomaMenQOL 2NCT07376473
Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas
An observational study of Intracranial Meningioma and Meningioma, run by Centre Hospitalier St Anne.
Trial summary
This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intracranial Meningioma, Meningioma, Health-related Quality of Life
- What is being tested?
- Quality-of-life questionnaire administration
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 2 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with intracranial meningioma, recruited through three sources to maximize heterogeneity: (1) patients seen in consultation at GHU Paris-Sainte-Anne; (2) members of the AMAVEA patient association informed by email; and (3) patients proposed by partner teams after a call for participation within the French Society of Neurosurgery Neuro-Oncology Club and Skull Base Club, contacted by email and invited to complete online questionnaires via REDCap.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of intracranial meningioma on imaging and/or confirmed by surgery
Who cannot join
- Pregnant or breastfeeding
- Individuals deprived of liberty by judicial/administrative decision or under compulsory psychiatric care
- Insufficient French language proficiency/comprehension
- Unable to complete the questionnaires independently
- Unable to express non-opposition to participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Benoît HUDELIST, Dr contact
About this study
This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma.
Participants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care.
The study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and/or confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient/community networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.
Read the detailed description
Meningiomas are common intracranial tumors and may substantially affect psychological, social, and functional well-being, including in patients managed conservatively. However, validated meningioma-specific quality-of-life tools are limited. The MQOL questionnaire was originally developed as a patient-centered, meningioma-specific instrument; a prior French translation/adaptation and pilot evaluation has been conducted. This study (MenQOL2) is designed to complete an in-depth psychometric validation of the French version (MQOL-FR) in a larger cohort and to provide a descriptive assessment of quality of life in French patients with meningioma.
This is a single-center, non-interventional, questionnaire-based study with a single assessment (no follow-up). Adults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically will be invited. Exclusion criteria include inability to complete questionnaires independently, insufficient French comprehension, pregnancy/breastfeeding, legal deprivation of liberty, and individuals under compulsory psychiatric care.
Participants receive study information (in clinic when applicable, otherwise by email) and access a secure REDCap link. Non-opposition is recorded online prior to questionnaire completion. Participants complete MQOL-FR (70 items), EQ-5D-5L, and FACT-Br. The total completion time is estimated at 30-45 minutes; completion may be split into multiple sessions using a REDCap-provided access code. Data are collected directly in REDCap and stored in pseudonymized form.
Primary outcome is psychometric performance of MQOL-FR, including dimensionality/structural validity, internal consistency (e.g., Cronbach's alpha), construct and convergent validity against EQ-5D-5L and FACT-Br, completeness rates, and floor/ceiling effects. Secondary objectives are descriptive and exploratory: to summarize MQOL-FR, EQ-5D-5L, and FACT-Br scores in the overall cohort and compare subgroups (e.g., WHO grade, sporadic vs progestin-associated, symptomatic vs asymptomatic, skull base vs convexity, tumor size, single vs multiple lesions, and management strategy). Exploratory modeling (ANCOVA/regression) will be used to assess factors associated with MQOL-FR scores. The targeted analyzable sample is 100 complete MQOL-FR responses; based on prior completion rates, approximately 238 patients will be contacted to achieve this target. In accordance with the collaboration with the original MQOL developers, de-identified score data may be shared for scientific purposes.
- Being tested
- Quality-of-life questionnaire administration
- Keywords
- meningioma, intracranial meningioma, quality of life, health-related quality of life, HRQoL, patient-reported outcomes, PRO, questionnaire validation, psychometric validation, MQOL, FACT-Br, EQ-5D-5L, REDCap, neurosurgery
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-life questionnaire administrationOther
Single-session completion of patient-reported outcome questionnaires: MQOL-FR (meningioma-specific), EQ-5D-5L, and FACT-Br, administered online via REDCap (approximately 30-45 minutes; may be completed in multiple sittings).
| Study group | Role | What they receive |
|---|---|---|
| Meningioma cohort | Adults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically. Participants complete a single online, self-administered questionnaire session via a secure REDCap link. There is no study-related treatment, no additional visit, and usual care is unchanged. Receives: Other: Quality-of-life questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects)
The MQOL-FR is the French translation of the Meningioma Quality of Life questionnaire (MQOL), a self-administered, meningioma-specific health-related quality-of-life instrument (70 items across 9 domains). Total score range: 0 to 100; higher scores indicate a better outcome (better quality of life).
Measured: Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial MeningiomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376473
- Sponsor's protocol ID
- D25-P039
- Acronym
- MenQOL 2
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas
- ClinicalTrials.gov ID
- NCT07376473
- Acronym / sponsor ID
- MenQOL 2 / D25-P039
- Keywords
- meningioma, intracranial meningioma, quality of life, health-related quality of life, HRQoL, patient-reported outcomes, PRO, questionnaire validation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma.
Participants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care.
The study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and/or confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient/community networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.
Detailed description
Meningiomas are common intracranial tumors and may substantially affect psychological, social, and functional well-being, including in patients managed conservatively. However, validated meningioma-specific quality-of-life tools are limited. The MQOL questionnaire was originally developed as a patient-centered, meningioma-specific instrument; a prior French translation/adaptation and pilot evaluation has been conducted. This study (MenQOL2) is designed to complete an in-depth psychometric validation of the French version (MQOL-FR) in a larger cohort and to provide a descriptive assessment of quality of life in French patients with meningioma.
This is a single-center, non-interventional, questionnaire-based study with a single assessment (no follow-up). Adults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically will be invited. Exclusion criteria include inability to complete questionnaires independently, insufficient French comprehension, pregnancy/breastfeeding, legal deprivation of liberty, and individuals under compulsory psychiatric care.
Participants receive study information (in clinic when applicable, otherwise by email) and access a secure REDCap link. Non-opposition is recorded online prior to questionnaire completion. Participants complete MQOL-FR (70 items), EQ-5D-5L, and FACT-Br. The total completion time is estimated at 30-45 minutes; completion may be split into multiple sessions using a REDCap-provided access code. Data are collected directly in REDCap and stored in pseudonymized form.
Primary outcome is psychometric performance of MQOL-FR, including dimensionality/structural validity, internal consistency (e.g., Cronbach's alpha), construct and convergent validity against EQ-5D-5L and FACT-Br, completeness rates, and floor/ceiling effects. Secondary objectives are descriptive and exploratory: to summarize MQOL-FR, EQ-5D-5L, and FACT-Br scores in the overall cohort and compare subgroups (e.g., WHO grade, sporadic vs progestin-associated, symptomatic vs asymptomatic, skull base vs convexity, tumor size, single vs multiple lesions, and management strategy). Exploratory modeling (ANCOVA/regression) will be used to assess factors associated with MQOL-FR scores. The targeted analyzable sample is 100 complete MQOL-FR responses; based on prior completion rates, approximately 238 patients will be contacted to achieve this target. In accordance with the collaboration with the original MQOL developers, de-identified score data may be shared for scientific purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meningioma cohort | – | Other: Quality-of-life questionnaire administrationAdults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically. Participants complete a single online, self-administered questionnaire session via a secure REDCap link. There is no study-related treatment, no additional visit, and usual care is unchanged. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with intracranial meningioma, recruited through three sources to maximize heterogeneity: (1) patients seen in consultation at GHU Paris-Sainte-Anne; (2) members of the AMAVEA patient association informed by email; and (3) patients proposed by partner teams after a call for participation within the French Society of Neurosurgery Neuro-Oncology Club and Skull Base Club, contacted by email and invited to complete online questionnaires via REDCap.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosis of intracranial meningioma on imaging and/or confirmed by surgery
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding
- Individuals deprived of liberty by judicial/administrative decision or under compulsory psychiatric care
- Insufficient French language proficiency/comprehension
- Unable to complete the questionnaires independently
- Unable to express non-opposition to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-life questionnaire administrationSingle-session completion of patient-reported outcome questionnaires: MQOL-FR (meningioma-specific), EQ-5D-5L, and FACT-Br, administered online via REDCap (approximately 30-45 minutes; may be completed in multiple sittings). | Other | Meningioma cohort |
Primary outcome
Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects)
Time frame: Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).
The MQOL-FR is the French translation of the Meningioma Quality of Life questionnaire (MQOL), a self-administered, meningioma-specific health-related quality-of-life instrument (70 items across 9 domains). Total score range: 0 to 100; higher scores indicate a better outcome (better quality of life).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoît HUDELIST, Dr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Meningioma and Meningioma, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane AWASSI (0145658486 ext. +33, v.awassi@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects) (time frame: Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.