Malignant GliomaNCT02300532
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
An observational study of Malignant Glioma, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Glioma
- How many people
- 561 participants
- Where
- 2 sitesJapan
- Study dates
- 10 Jan 2013to 24 Mar 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosed malignant glioma treated by surgery
Who may be able to join
- All-patient of Gliadel implantation
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.
- Conditions
- Malignant Glioma
- Being tested
- No intervention
- Keywords
- Malignant Glioma, Glioblastoma Multiforme
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events/Serious Adverse Events
Measured: Up to 3 months
Secondary outcomes (1)
Survival rate
Survival rate of subjects measured up to 1 year after implantation of Gliadel
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start10 Jan 2013
- Primary completion10 Jul 2014
- Study completion24 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300532
- Sponsor's protocol ID
- GLI01S
- Status last verified
- Jan 2017
- First submitted
- 21 Nov 2014
- Last updated
- 27 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
- ClinicalTrials.gov ID
- NCT02300532
- Acronym / sponsor ID
- GLI01S
- Conditions
- Malignant Glioma
- Keywords
- Malignant Glioma, Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 24 Mar 2015 (actual)
- First posted
- 25 Nov 2014 (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.
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No interventionPatients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosed malignant glioma treated by surgery
Key inclusion criteria (1 listed)
- All-patient of Gliadel implantation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No intervention | Other | Cohort 1 |
Primary outcome
Number of Adverse Events/Serious Adverse Events
Time frame: Up to 3 months
1 secondary outcome
Survival rate
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma, run by Eisai Co., Ltd. at 2 sites in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Events/Serious Adverse Events (time frame: Up to 3 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 27 Feb 2017.