Meningioma AtypicalTransMenAtypNCT05259332
Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas
An observational study of Meningioma Atypical, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II). Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma Atypical
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).
Who may be able to join
- Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
- At least one postoperative follow-up visit.
- Adult patients (>18 yo) at the time of the intervention.
- Surgical excision.
Who cannot join
- History of meningioma in the same location.
- Neo-adjuvant treatment.
- Absence of non-objection form.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Guillaume GAUCHOTTE
Vandœuvre-lès-Nancy, Lorraine, 54511
Guillaume GAUCHOTTE, PU-PH, +33 3 83 65 60 17, guillaume.gauchotte@univ-lorraine.fr
Emilie BECKER, Resident, +33 6 73 11 96 42, emilie.becker54@gmail.com
About this study
Official title: Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications
Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).
Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.
- Conditions
- Meningioma Atypical
- Keywords
- Transcriptome
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression being defined by a growth (mm3) of the tumor objectified by imaging.
Measured: through study completion an average of 5 years.
Secondary outcomes (5)
Tumor volume assessed by imaging pre- and post-operative
mm3; RECIST criteria
Measured: before and within 3 months after surgery
mRNA quantities of transcripts of interest
µg.mL-1
Measured: through study completion, an average of 1 year
Radiotherapy-induced toxicity
CTCAE scale (Common Terminology Criteria for Adverse Events) v 4.0
Measured: within 5 years after radiotherapy
Dose of corticosteroids before and after radiotherapy
in mg
Measured: within 6 months before and after radiotherapy
Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.
Kappa coefficient
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start25 Feb 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningioma AtypicalStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume GAUCHOTTE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259332
- Sponsor's protocol ID
- 2020PI026
- Acronym
- TransMenAtyp
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 28 Feb 2022
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications
- ClinicalTrials.gov ID
- NCT05259332
- Acronym / sponsor ID
- TransMenAtyp / 2020PI026
- Conditions
- Meningioma Atypical
- Keywords
- Transcriptome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 25 Feb 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 28 Feb 2022 (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.
Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).
Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).
Key inclusion criteria (4 listed)
- Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
- At least one postoperative follow-up visit.
- Adult patients (>18 yo) at the time of the intervention.
- Surgical excision.
Key exclusion criteria (3 listed)
- History of meningioma in the same location.
- Neo-adjuvant treatment.
- Absence of non-objection form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: through study completion an average of 5 years.
Progression being defined by a growth (mm3) of the tumor objectified by imaging.
5 secondary outcomes
Tumor volume assessed by imaging pre- and post-operative
Time frame: before and within 3 months after surgery
mRNA quantities of transcripts of interest
Time frame: through study completion, an average of 1 year
Radiotherapy-induced toxicity
Time frame: within 5 years after radiotherapy
Dose of corticosteroids before and after radiotherapy
Time frame: within 6 months before and after radiotherapy
Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma Atypical, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume GAUCHOTTE, PUPH (+33 3 83 65 60 17, g.gauchotte@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: through study completion an average of 5 years.). 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 28 Feb 2022.