NCT01305122

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2018

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

7.7 years

First QC Date

February 25, 2011

Last Update Submit

February 5, 2021

Conditions

OMS Grade II Glioma

Keywords

GliomaNeurocognitive functions

Outcome Measures

Primary Outcomes (1)

  • MoCA test

    36 months

Study Arms (1)

OMS grade II glioma

OTHER

neurocognitive tests

Behavioral: neurocognitive tests

Interventions

neurocognitive testsBEHAVIORAL

* inclusion * 1 year * 3 years * 5 years

Also known as: -MoCA test, - fNART, - Hopkins Verbal Learning test, - Test 10/36, - TEA, - Stroop, - DO80, - VOSP, - Beery, - BDAE, - Token test, - BDI, - STAI, - QLQ-C30 and BN20
OMS grade II glioma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OMS grade II glioma
  • signed informed consent
  • age \>=18
  • IK \>=80%
  • ability to read, write and undertand French

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CH Amiens-Picardie

Amiens, 80054, France

Location

Institut de Cancérologie de l'Ouest

Angers, 49933, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Saint André

Bordeaux, 33000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59037, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hôpital d'instruction des armées Desgenettes

Lyon, 69275, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital Guy de Chauliac

Montpellier, 34295, France

Location

Hôpital Central de Nancy

Nancy, 54035, France

Location

Hôpital Pasteur

Nice, 06000, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Pitié Salpêtrière

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Hôpital Maison Blanche

Reims, 51092, France

Location

CHU Charles NICOLLE

Rouen, 76031, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre René Gauducheau

Saint-Herblain, France

Location

CH Valenciennes

Valenciennes, 59322, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Glioma

Interventions

Mental Status and Dementia TestsTeaStroop Test

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marie-Pierre SUNYACH, MD

    Centre Léon Bérard, Lyon - FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

February 1, 2011

Primary Completion

October 21, 2018

Study Completion

October 21, 2018

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

FR(21)