Malignant GliomaNCT02300506
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
An observational study of Malignant Glioma, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Glioma
- How many people
- 507 participants
- Where
- 2 sitesJapan
- Study dates
- 10 Jan 2014to 10 Jul 2016
- 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
- Malignant Glioma, patients enrolled in study GLI01S.
Who cannot join
- Corresponding to contraindication of Gliadel.
- Not applicable to indications of Gliadel.
Trial locations and contacts
2 sites in 1 country.
About this study
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).
- 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, and enrolled in study GLI01S. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Survival rate of subjects measured up to 3 year after implantation
Measured: Up to 3 years
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 2014
- Primary completion10 Jul 2016
- Study completion10 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 507 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
- NCT02300506
- Sponsor's protocol ID
- GLI02T
- Status last verified
- Aug 2017
- First submitted
- 21 Nov 2014
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Iuchi T, Inoue A, Hirose Y, Morioka M, Horiguchi K, Natsume A, Arakawa Y, Iwasaki K, Fujiki M, Kumabe T, Sakata Y. Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan. Neurooncol Adv. 2022 Jan 12;4(1):vdab189. doi: 10.1093/noajnl/vdab189. eCollection 2022 Jan-Dec.
PubMed 35118382
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
- ClinicalTrials.gov ID
- NCT02300506
- Acronym / sponsor ID
- GLI02T
- Conditions
- Malignant Glioma
- Keywords
- Malignant Glioma, Glioblastoma multiforme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (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.
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).
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, and enrolled in study GLI01S. |
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)
- Malignant Glioma, patients enrolled in study GLI01S.
Key exclusion criteria (2 listed)
- Corresponding to contraindication of Gliadel.
- Not applicable to indications of Gliadel.
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
Survival rate
Time frame: Up to 3 years
Survival rate of subjects measured up to 3 year after implantation
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 5 Nov 2018.
- Derived from this study: PubMed 35118382Iuchi T, Inoue A, Hirose Y, Morioka M, Horiguchi K, Natsume A, Arakawa Y, Iwasaki K, Fujiki M, Kumabe T, Sakata Y. Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan. Neurooncol Adv. 2022 Jan 12;4(1):vdab189. doi: 10.1093/noajnl/vdab189. eCollection 2022 Jan-Dec.
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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 2 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 5 Nov 2018. 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?
Survival rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300506, which also lists 1 linked publication.
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 5 Nov 2018.