Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma

Not Applicable

Terminated

• Conditions: OMS Grade II Glioma
• Interventions: Behavioral: neurocognitive tests

• Registration Number: NCT01305122
• Lead Sponsor: Centre Leon Berard

Brief Summary

This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.

* cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)

* cohort B: patients with disease simple monitoring.

The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2018-10-21
• Study Completion: 2018-10-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• OMS grade II glioma
• signed informed consent
• age >=18
• IK >=80%
• ability to read, write and undertand French

Exclusion Criteria

• glioma localized to brainstem
• other neurologic or psychiatric disease
• history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization
• neuroleptic concomitant treatment
• pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OMS grade II glioma	neurocognitive tests	neurocognitive tests

Primary Outcome Measures

Name	Time	Method
MoCA test	36 months

Trial Locations

Locations (21)

CH Amiens-Picardie; 🇫🇷 Amiens, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

Centre Georges François Leclerc; 🇫🇷 DIJON Cedex, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Angers, France

Hôpital Jean Minjoz; 🇫🇷 BESANCON Cedex, France

Centre Oscar Lambret; 🇫🇷 LILLE Cedex, France

CHRU de Lille; 🇫🇷 LILLE Cedex, France

Hôpital d'instruction des armées Desgenettes; 🇫🇷 LYON Cedex 03, France

Centre Léon Bérard; 🇫🇷 LYON Cedex 08, France

Centre Antoine Lacassagne; 🇫🇷 NICE Cedex 2, France

Hôpital Pasteur; 🇫🇷 Nice, France

Hôpital Pitié Salpêtrière; 🇫🇷 PARIS Cedex 13, France

Hôpital Maison Blanche; 🇫🇷 REIMS Cedex, France

Centre Henri Becquerel; 🇫🇷 ROUEN Cedex 1, France

CHU Charles NICOLLE; 🇫🇷 Rouen, France

CH Valenciennes; 🇫🇷 Valenciennes, France

Centre Alexis Vautrin; 🇫🇷 VANDOEUVRE LES NANCY Cedex, France

Hôpital Guy de Chauliac; 🇫🇷 MONTPELLIER Cedex 5, France

Hôpital Central de Nancy; 🇫🇷 NANCY Cedex, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France