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

NCT ID: NCT01305122

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2018-10-21

Brief Summary

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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

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Conditions

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OMS Grade II Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OMS grade II glioma

neurocognitive tests

Group Type OTHER

neurocognitive tests

Intervention Type BEHAVIORAL

* inclusion
* 1 year
* 3 years
* 5 years

Interventions

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neurocognitive tests

* inclusion
* 1 year
* 3 years
* 5 years

Intervention Type BEHAVIORAL

Other Intervention Names

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-MoCA test - fNART - Hopkins Verbal Learning test - Test 10/36 - TEA - Stroop - DO80 - VOSP - Beery - BDAE - Token test - BDI - STAI - QLQ-C30 and BN20

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Leon Berard

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Pierre SUNYACH, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon - FRANCE

Locations

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CH Amiens-Picardie

Amiens, , France

Site Status

Institut de Cancérologie de l'Ouest

Angers, , France

Site Status

Hôpital Jean Minjoz

Besançon, , France

Site Status

Hôpital Saint André

Bordeaux, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

Hôpital d'instruction des armées Desgenettes

Lyon, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Hôpital Guy de Chauliac

Montpellier, , France

Site Status

Hôpital Central de Nancy

Nancy, , France

Site Status

Hôpital Pasteur

Nice, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Hôpital Pitié Salpêtrière

Paris, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Hôpital Maison Blanche

Reims, , France

Site Status

CHU Charles NICOLLE

Rouen, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre René Gauducheau

Saint-Herblain, , France

Site Status

CH Valenciennes

Valenciennes, , France

Site Status

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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TUMEURS GLIALES

Identifier Type: -

Identifier Source: org_study_id

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