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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01305122
Recruitment Status : Recruiting
First Posted : February 28, 2011
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

Study Description
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
OMS Grade II Glioma Behavioral: neurocognitive tests

Study Design

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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01305122

Contact: Ellen BLANC (0)4 78 78 29 67 ext +33 ellen.blanc@lyon.unicancer.fr
Contact: Valérie FOUILLAT (0)4 78 78 79 39 valerie.fouillat@lyon.unicancer.fr

CH Amiens-Picardie Active, not recruiting
Amiens, France, 80054
Institut de Cancérologie de l'Ouest Not yet recruiting
Angers, France, 49933
Principal Investigator: Mario CAMPONE, MD         
Sub-Investigator: Sophie LEBOUVIER-SADOT, MD         
Sub-Investigator: Emmanuelle BOURBOULOUX, MD         
Sub-Investigator: Dominique BERTON-RIGAUD, MD         
Sub-Investigator: Jean-Sébastien FRENEL, MD         
Hôpital Jean Minjoz Not yet recruiting
BESANCON Cedex, France, 25030
Principal Investigator: Marie-Hélène BARON-MAILLOT, MD         
Hôpital Saint André Active, not recruiting
Bordeaux, France, 33000
Hôpital Neurologique Active, not recruiting
BRON Cedex, France, 69677
Centre Georges François Leclerc Not yet recruiting
DIJON Cedex, France, 21079
Principal Investigator: Gilles TRUC, MD         
Centre Oscar Lambret Active, not recruiting
LILLE Cedex, France, 59037
CHRU de Lille Recruiting
LILLE Cedex, France, 59037
Principal Investigator: Emilie LE RHUN, MD         
Sub-Investigator: François DUBOIS, MD         
Sub-Investigator: Christine DELMAIRE, MD         
Sub-Investigator: Sabine CARON, MD         
Sub-Investigator: Serge BLOND, MD         
Sub-Investigator: Carole RAMIREZ, MD         
Hôpital d'instruction des armées Desgenettes Recruiting
LYON Cedex 03, France, 69275
Principal Investigator: Laurent GUILLOTON, MD         
Centre Léon Bérard Active, not recruiting
LYON Cedex 08, France, 69373
Hôpital Guy de Chauliac Active, not recruiting
MONTPELLIER Cedex 5, France, 34295
Hôpital Central de Nancy Recruiting
NANCY Cedex, France, 54035
Principal Investigator: Luc TAILLANDIER, MD         
Sub-Investigator: Catherine PINELLI, MD         
Sub-Investigator: Patrick BEAUCHESNE, MD         
Centre Antoine Lacassagne Active, not recruiting
NICE Cedex 2, France, 06189
Hôpital Pasteur Recruiting
Nice, France, 06000
Principal Investigator: Denys FONTAINE, MD         
Sub-Investigator: Christine LEBRUN-FRENAY, MD         
Hôpital Pitié Salpêtrière Recruiting
PARIS Cedex 13, France, 75651
Principal Investigator: Caroline HOUILLIER, MD         
Sub-Investigator: Loïc FEUVRET, MD         
Sub-Investigator: Laurent CAPELLE, MD         
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre Benite, France, 69310
Principal Investigator: Anne D'HOMBRES, MD         
Hôpital Maison Blanche Active, not recruiting
REIMS Cedex, France, 51092
Centre Henri Becquerel Not yet recruiting
ROUEN Cedex 1, France, 76038
Principal Investigator: HANZEN, MD         
Sub-Investigator: Fernand MISSOHOU, MD         
CHU Charles NICOLLE Not yet recruiting
Rouen, France, 76031
Principal Investigator: Olivier MARTINAUD, MD         
Centre René Gauducheau Not yet recruiting
Saint Herblain, France
Principal Investigator: Maud AUMONT, MD         
CH Valenciennes Not yet recruiting
Valenciennes, France, 59322
Principal Investigator: Emilie LE RHUN, MD         
Centre Alexis Vautrin Not yet recruiting
VANDOEUVRE LES NANCY Cedex, France, 54511
Principal Investigator: Valérie BERNIER, MD         
Sponsors and Collaborators
Centre Leon Berard
Ministry of Health, France
Principal Investigator: Marie-Pierre SUNYACH, MD Centre Léon Bérard, Lyon - FRANCE
More Information

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01305122     History of Changes
Other Study ID Numbers: TUMEURS GLIALES
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

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