Oncological Care for Patients With Meningioma

NCT02973256 | Unknown DMC

• 1 other identifier: UF9759
• Study Type: observational
• Target: 1,204
• Locations: 1 country
• Sites: 1

Brief Summary

Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available. Here, we propose to study clinical, pathological, radiological and therapeutic factors of an exhaustive population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to assess the impact of postoperative radiotherapy, or the absence of postoperative radiotherapy, on overall survival and on quality of life

Conditions

Atypical Meningioma; Clear-cell Meningioma; Chordoid Meningioma; Anaplastic Meningioma; Rhabdoid Meningioma; Papillary Meningioma

Keywords

Meningioma grade II; Meningioma grade III

Outcome Measures

Primary Outcomes (1)

• overall survival

  Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news

  up to 10 years, since diagnosis

Secondary Outcomes (2)

• the tumor growth

  up to 10 years, since diagnosis

• Progression/Recurrence Free Survival, will be measured by month

  up to 10 years, since diagnosis

Other Outcomes (2)

• Evaluation of the quality of life

  baseline, 6 months, 12 months 18 months

• diagnosis of the central pathological review.

  1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a histological diagnosis of GIIM and GIIIM in metropolitan France

You may not qualify if:

• Patient with GIM
• Non-operated meningioma patient

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Besancon: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• LUC BAUCHET, MD, PhD

  UH MONTPELLIER

  STUDY DIRECTOR

Central Study Contacts

LUC BAUCHET, MD, PhD

CONTACT

467337205; l-bauchet@chu-montpellier.fr

Frank BONNETAIN

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: November 25, 2016
• Study Start: January 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)