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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305122
Recruitment Status : Active, not recruiting
First Posted : February 28, 2011
Last Update Posted : February 28, 2018
Ministry of Health, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
OMS Grade II Glioma Behavioral: neurocognitive tests Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
Study Start Date : February 2011
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. MoCA test [ Time Frame: 36 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305122

CH Amiens-Picardie
Amiens, France, 80054
Institut de Cancérologie de l'Ouest
Angers, France, 49933
Hôpital Jean Minjoz
BESANCON Cedex, France, 25030
Hôpital Saint André
Bordeaux, France, 33000
Hôpital Neurologique
BRON Cedex, France, 69677
Centre Georges François Leclerc
DIJON Cedex, France, 21079
Centre Oscar Lambret
LILLE Cedex, France, 59037
CHRU de Lille
LILLE Cedex, France, 59037
Hôpital d'instruction des armées Desgenettes
LYON Cedex 03, France, 69275
Centre Léon Bérard
LYON Cedex 08, France, 69373
Hôpital Guy de Chauliac
MONTPELLIER Cedex 5, France, 34295
Hôpital Central de Nancy
NANCY Cedex, France, 54035
Centre Antoine Lacassagne
NICE Cedex 2, France, 06189
Hôpital Pasteur
Nice, France, 06000
Hôpital Pitié Salpêtrière
PARIS Cedex 13, France, 75651
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Hôpital Maison Blanche
REIMS Cedex, France, 51092
Centre Henri Becquerel
ROUEN Cedex 1, France, 76038
Rouen, France, 76031
Centre René Gauducheau
Saint Herblain, France
CH Valenciennes
Valenciennes, France, 59322
Centre Alexis Vautrin
VANDOEUVRE LES NANCY Cedex, France, 54511
Sponsors and Collaborators
Centre Leon Berard
Ministry of Health, France
Principal Investigator: Marie-Pierre SUNYACH, MD Centre Léon Bérard, Lyon - FRANCE

Responsible Party: Centre Leon Berard Identifier: NCT01305122     History of Changes
Other Study ID Numbers: TUMEURS GLIALES
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Centre Leon Berard:
Neurocognitive functions

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue