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

Primary Purpose

OMS Grade II Glioma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neurocognitive tests
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OMS Grade II Glioma focused on measuring Glioma, Neurocognitive functions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Amiens-Picardie
  • Institut de Cancérologie de l'Ouest
  • Hôpital Jean Minjoz
  • Hôpital Saint André
  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • CHRU de Lille
  • Hôpital d'instruction des armées Desgenettes
  • Centre Léon Bérard
  • Hôpital Guy de Chauliac
  • Hôpital Central de Nancy
  • Centre Antoine Lacassagne
  • Hôpital Pasteur
  • Hôpital Pitié Salpêtrière
  • Centre Hospitalier Lyon Sud
  • Hôpital Maison Blanche
  • Centre Henri Becquerel
  • CHU Charles NICOLLE
  • Centre René Gauducheau
  • CH Valenciennes
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OMS grade II glioma

Arm Description

neurocognitive tests

Outcomes

Primary Outcome Measures

MoCA test

Secondary Outcome Measures

Full Information

First Posted
February 25, 2011
Last Updated
February 5, 2021
Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01305122
Brief Title
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma
Official Title
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment too low
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 21, 2018 (Actual)
Study Completion Date
October 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OMS Grade II Glioma
Keywords
Glioma, Neurocognitive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMS grade II glioma
Arm Type
Other
Arm Description
neurocognitive tests
Intervention Type
Behavioral
Intervention Name(s)
neurocognitive tests
Other Intervention Name(s)
-MoCA test, - fNART, - Hopkins Verbal Learning test, - Test 10/36, - TEA, - Stroop, - DO80, - VOSP, - Beery, - BDAE, - Token test, - BDI, - STAI, - QLQ-C30 and BN20
Intervention Description
inclusion 1 year 3 years 5 years
Primary Outcome Measure Information:
Title
MoCA test
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre SUNYACH, MD
Organizational Affiliation
Centre Léon Bérard, Lyon - FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Jean Minjoz
City
BESANCON Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Georges François Leclerc
City
DIJON Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU de Lille
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital d'instruction des armées Desgenettes
City
LYON Cedex 03
ZIP/Postal Code
69275
Country
France
Facility Name
Centre Léon Bérard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Guy de Chauliac
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Central de Nancy
City
NANCY Cedex
ZIP/Postal Code
54035
Country
France
Facility Name
Centre Antoine Lacassagne
City
NICE Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Pitié Salpêtrière
City
PARIS Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Hôpital Maison Blanche
City
REIMS Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Henri Becquerel
City
ROUEN Cedex 1
ZIP/Postal Code
76038
Country
France
Facility Name
CHU Charles NICOLLE
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
Country
France
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Centre Alexis Vautrin
City
VANDOEUVRE LES NANCY Cedex
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

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

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