OMS Grade II Glioma Clinical Trial
Official title:
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
| Verified date | February 2021 |
| Source | Centre Leon Berard |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 112 |
| Est. completion date | October 21, 2018 |
| Est. primary completion date | October 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CH Amiens-Picardie | Amiens | |
| France | Institut de Cancérologie de l'Ouest | Angers | |
| France | Hôpital Jean Minjoz | BESANCON Cedex | |
| France | Hôpital Saint André | Bordeaux | |
| France | Centre Georges François Leclerc | DIJON Cedex | |
| France | Centre Oscar Lambret | LILLE Cedex | |
| France | CHRU de Lille | LILLE Cedex | |
| France | Hôpital d'instruction des armées Desgenettes | LYON Cedex 03 | |
| France | Centre Léon Bérard | LYON Cedex 08 | |
| France | Hôpital Guy de Chauliac | MONTPELLIER Cedex 5 | |
| France | Hôpital Central de Nancy | NANCY Cedex | |
| France | Hôpital Pasteur | Nice | |
| France | Centre Antoine Lacassagne | NICE Cedex 2 | |
| France | Hôpital Pitié Salpêtrière | PARIS Cedex 13 | |
| France | Centre Hospitalier Lyon Sud | Pierre Benite | |
| France | Hôpital Maison Blanche | REIMS Cedex | |
| France | CHU Charles NICOLLE | Rouen | |
| France | Centre Henri Becquerel | ROUEN Cedex 1 | |
| France | Centre René Gauducheau | Saint Herblain | |
| France | CH Valenciennes | Valenciennes | |
| France | Centre Alexis Vautrin | VANDOEUVRE LES NANCY Cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Leon Berard | Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MoCA test | 36 months |