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

February 5, 2021 updated by: Centre Leon Berard

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CH Amiens-Picardie
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest
      • BESANCON Cedex, France, 25030
        • Hopital Jean Minjoz
      • Bordeaux, France, 33000
        • Hopital Saint André
      • DIJON Cedex, France, 21079
        • Centre Georges François Leclerc
      • LILLE Cedex, France, 59037
        • CHRU de Lille
      • LILLE Cedex, France, 59037
        • Centre Oscar Lambret
      • LYON Cedex 03, France, 69275
        • Hôpital d'Instruction des Armées Desgenettes
      • LYON Cedex 08, France, 69373
        • Centre Leon Berard
      • MONTPELLIER Cedex 5, France, 34295
        • Hôpital Guy de Chauliac
      • NANCY Cedex, France, 54035
        • Hôpital Central de Nancy
      • NICE Cedex 2, France, 06189
        • Centre Antoine Lacassagne
      • Nice, France, 06000
        • Hôpital Pasteur
      • PARIS Cedex 13, France, 75651
        • Hôpital Pitié Salpêtrière
      • Pierre Benite, France, 69310
        • Centre Hospitalier Lyon Sud
      • REIMS Cedex, France, 51092
        • Hopital Maison Blanche
      • ROUEN Cedex 1, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76031
        • CHU Charles Nicolle
      • Saint Herblain, France
        • Centre Rene Gauducheau
      • VANDOEUVRE LES NANCY Cedex, France, 54511
        • Centre Alexis Vautrin
      • Valenciennes, France, 59322
        • CH Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: OMS grade II glioma
neurocognitive tests
Behavioral: neurocognitive tests
  • inclusion
  • 1 year
  • 3 years
  • 5 years
Other Names:
  • -MoCA test
  • - fNART
  • - Hopkins Verbal Learning test
  • - Test 10/36
  • - TEA
  • - Stroop
  • - DO80
  • - VOSP
  • - Beery
  • - BDAE
  • - Token test
  • - BDI
  • - STAI
  • - QLQ-C30 and BN20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MoCA test
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Marie-Pierre SUNYACH, MD, Centre Léon Bérard, Lyon - FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

October 21, 2018

Study Completion (ACTUAL)

October 21, 2018

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (ESTIMATE)

February 28, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUMEURS GLIALES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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