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

This study is currently recruiting participants.
Verified March 2013 by Centre Leon Berard
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01305122
First received: February 25, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
OMS Grade II Glioma
 Behavioral: neurocognitive tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • MoCA test [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 183
Study Start Date: February 2011
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305122

Contacts
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

Locations
France
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            
Hôpital Pasteur Recruiting
Nice, France, 06000
Principal Investigator: Denys FONTAINE, MD            
Sub-Investigator: Christine LEBRUN-FRENAY, MD            
Centre Antoine Lacassagne Active, not recruiting
NICE Cedex 2, France, 06189
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
CHU Charles NICOLLE Not yet recruiting
Rouen, France, 76031
Principal Investigator: Olivier MARTINAUD, MD            
Centre Henri Becquerel Not yet recruiting
ROUEN Cedex 1, France, 76038
Principal Investigator: HANZEN, MD            
Sub-Investigator: Fernand MISSOHOU, 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
Investigators
Principal Investigator: Marie-Pierre SUNYACH, MD Centre Léon Bérard, Lyon - FRANCE
  More Information

No publications provided

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01305122     History of Changes
Other Study ID Numbers: TUMEURS GLIALES
Study First Received: February 25, 2011
Last Updated: March 20, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Keywords provided by Centre Leon Berard:
Glioma
Neurocognitive functions

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

ClinicalTrials.gov processed this record on May 22, 2013