Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

NCT ID: NCT02300506

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-10

Study Completion Date

2016-07-10

Brief Summary

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The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).

Detailed Description

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Conditions

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Malignant Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg, and enrolled in study GLI01S.

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Malignant Glioma, patients enrolled in study GLI01S.

Exclusion Criteria

* Corresponding to contraindication of Gliadel.
* Not applicable to indications of Gliadel.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Osaka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 35118382 (View on PubMed)

Other Identifiers

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GLI02T

Identifier Type: -

Identifier Source: org_study_id

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