OMS Grade II GliomaNCT01305122
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma
A study testing neurocognitive tests in people with OMS Grade II Glioma, run by Centre Leon Berard at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OMS Grade II Glioma
- What is being tested?
- neurocognitive tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 21 sitesFrance
- Study dates
- Feb 2011to 21 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OMS grade II glioma
- signed informed consent
- age >=18
- IK >=80%
- ability to read, write and undertand French
Who cannot join
- 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 locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CH Amiens-Picardie
Amiens, 80054
Institut de Cancérologie de l'Ouest
Angers, 49933
Hôpital Jean Minjoz
Besançon, 25030
Hôpital Saint André
Bordeaux, 33000
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59037
CHRU de Lille
Lille, 59037
Hôpital d'instruction des armées Desgenettes
Lyon, 69275
Centre Léon Bérard
Lyon, 69373
Hôpital Guy de Chauliac
Montpellier, 34295
Hôpital Central de Nancy
Nancy, 54035
Hôpital Pasteur
Nice, 06000
Centre Antoine Lacassagne
Nice, 06189
Hôpital Pitié Salpêtrière
Paris, 75651
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Hôpital Maison Blanche
Reims, 51092
CHU Charles NICOLLE
Rouen, 76031
Centre Henri Becquerel
Rouen, 76038
Centre René Gauducheau
Saint-Herblain
CH Valenciennes
Valenciennes, 59322
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
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.
- Conditions
- OMS Grade II Glioma
- Being tested
- neurocognitive tests
- Keywords
- Glioma, Neurocognitive functions
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive testsBehavioural
Also called -MoCA test, - fNART, - Hopkins Verbal Learning test, - Test 10/36
- inclusion
- 1 year
- 3 years
- 5 years
| Study group | Role | What they receive |
|---|---|---|
| OMS grade II glioma | Other | neurocognitive tests Receives: Behavioral: neurocognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA test
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completion21 Oct 2018
- Study completion21 Oct 2018
Why it stopped: Recruitment too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OMS Grade II GliomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre SUNYACH, MD, Principal investigator, Centre Léon Bérard, Lyon - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305122
- Sponsor's protocol ID
- TUMEURS GLIALES
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2011
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
- ClinicalTrials.gov ID
- NCT01305122
- Acronym / sponsor ID
- TUMEURS GLIALES
- Conditions
- OMS Grade II Glioma
- Keywords
- Glioma, Neurocognitive functions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too low
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2011
- Primary completion
- 21 Oct 2018 (actual)
- Study completion
- 21 Oct 2018 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMS grade II glioma | Other | Behavioral: neurocognitive testsneurocognitive tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OMS grade II glioma
- signed informed consent
- age >=18
- IK >=80%
- ability to read, write and undertand French
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitive testsAlso: -MoCA test, - fNART, - Hopkins Verbal Learning test, - Test 10/36* inclusion * 1 year * 3 years * 5 years | Behavioural | OMS grade II glioma |
Primary outcome
MoCA test
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Recruitment too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pierre SUNYACH, MD principal investigator
Centre Léon Bérard, Lyon - FRANCE
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurocognitive tests in people with OMS Grade II Glioma, run by Centre Leon Berard at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA test (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.