Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas

NCT05259332 | Unknown

• 1 other identifier: 2020PI026
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression being defined by a growth (mm3) of the tumor objectified by imaging.

  through study completion an average of 5 years.

Secondary Outcomes (5)

• Tumor volume assessed by imaging pre- and post-operative

  before and within 3 months after surgery

• mRNA quantities of transcripts of interest

  through study completion, an average of 1 year

• Radiotherapy-induced toxicity

  within 5 years after radiotherapy

• Dose of corticosteroids before and after radiotherapy

  within 6 months before and after radiotherapy

• Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• History of meningioma in the same location.
• Neo-adjuvant treatment.
• Absence of non-objection form.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Guillaume GAUCHOTTE

Vandœuvre-lès-Nancy, Lorraine, 54511, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor samples (atypical meningiomas WHO grade II)

Central Study Contacts

Guillaume GAUCHOTTE, PUPH

CONTACT

+33 3 83 65 60 17; g.gauchotte@univ-lorraine.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor and Hospital practitioner

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 28, 2022
• Study Start: February 25, 2022
• Primary Completion: April 1, 2022
• Study Completion: October 31, 2023
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

FR (1)