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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01305122
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Leon Berard
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marie-Pierre SUNYACH, MD
Principal Investigator Affiliation Centre Léon Bérard, Lyon - FRANCE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

OMS Grade II Glioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CH Amiens-Picardie, Amiens, France

Status

Active, not recruiting

Address

CH Amiens-Picardie

Amiens, , 80054

Site Contact

(0)4 78 78 29 67

Institut de Cancérologie de l'Ouest, Angers, France

Status

Not yet recruiting

Address

Institut de Cancérologie de l'Ouest

Angers, , 49933

Site Contact

(0)4 78 78 29 67

Hôpital Jean Minjoz, BESANCON Cedex, France

Status

Not yet recruiting

Address

Hôpital Jean Minjoz

BESANCON Cedex, , 25030

Site Contact

(0)4 78 78 29 67

Hôpital Saint André, Bordeaux, France

Status

Active, not recruiting

Address

Hôpital Saint André

Bordeaux, , 33000

Site Contact

(0)4 78 78 29 67

Hôpital Neurologique, BRON Cedex, France

Status

Active, not recruiting

Address

Hôpital Neurologique

BRON Cedex, , 69677

Site Contact

(0)4 78 78 29 67

Centre Georges François Leclerc, DIJON Cedex, France

Status

Not yet recruiting

Address

Centre Georges François Leclerc

DIJON Cedex, , 21079

Site Contact

(0)4 78 78 29 67

Centre Oscar Lambret, LILLE Cedex, France

Status

Active, not recruiting

Address

Centre Oscar Lambret

LILLE Cedex, , 59037

Site Contact

(0)4 78 78 29 67

CHRU de Lille, LILLE Cedex, France

Status

Recruiting

Address

CHRU de Lille

LILLE Cedex, , 59037

Site Contact

(0)4 78 78 29 67

LYON Cedex 03, France

Status

Recruiting

Address

Hôpital d'instruction des armées Desgenettes

LYON Cedex 03, , 69275

Site Contact

(0)4 78 78 29 67

Centre Léon Bérard, LYON Cedex 08, France

Status

Active, not recruiting

Address

Centre Léon Bérard

LYON Cedex 08, , 69373

Site Contact

(0)4 78 78 29 67

Hôpital Guy de Chauliac, MONTPELLIER Cedex 5, France

Status

Active, not recruiting

Address

Hôpital Guy de Chauliac

MONTPELLIER Cedex 5, , 34295

Site Contact

(0)4 78 78 29 67

Hôpital Central de Nancy, NANCY Cedex, France

Status

Recruiting

Address

Hôpital Central de Nancy

NANCY Cedex, , 54035

Site Contact

(0)4 78 78 29 67

Centre Antoine Lacassagne, NICE Cedex 2, France

Status

Active, not recruiting

Address

Centre Antoine Lacassagne

NICE Cedex 2, , 06189

Site Contact

(0)4 78 78 29 67

Hôpital Pasteur, Nice, France

Status

Recruiting

Address

Hôpital Pasteur

Nice, , 06000

Site Contact

(0)4 78 78 29 67

Hôpital Pitié Salpêtrière, PARIS Cedex 13, France

Status

Recruiting

Address

Hôpital Pitié Salpêtrière

PARIS Cedex 13, , 75651

Site Contact

(0)4 78 78 29 67

Centre Hospitalier Lyon Sud, Pierre Benite, France

Status

Not yet recruiting

Address

Centre Hospitalier Lyon Sud

Pierre Benite, , 69310

Site Contact

(0)4 78 78 29 67

Hôpital Maison Blanche, REIMS Cedex, France

Status

Active, not recruiting

Address

Hôpital Maison Blanche

REIMS Cedex, , 51092

Site Contact

(0)4 78 78 29 67

Centre Henri Becquerel, ROUEN Cedex 1, France

Status

Not yet recruiting

Address

Centre Henri Becquerel

ROUEN Cedex 1, , 76038

Site Contact

(0)4 78 78 29 67

CHU Charles NICOLLE, Rouen, France

Status

Not yet recruiting

Address

CHU Charles NICOLLE

Rouen, , 76031

Site Contact

(0)4 78 78 29 67

Centre René Gauducheau, Saint Herblain, France

Status

Not yet recruiting

Address

Centre René Gauducheau

Saint Herblain, ,

Site Contact

(0)4 78 78 29 67

CH Valenciennes, Valenciennes, France

Status

Not yet recruiting

Address

CH Valenciennes

Valenciennes, , 59322

Site Contact

(0)4 78 78 29 67

Centre Alexis Vautrin, VANDOEUVRE LES NANCY Cedex, France

Status

Not yet recruiting

Address

Centre Alexis Vautrin

VANDOEUVRE LES NANCY Cedex, , 54511

Site Contact

(0)4 78 78 29 67

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