NCT02300506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2016

Completed
Last Updated

November 5, 2018

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

November 21, 2014

Last Update Submit

November 2, 2018

Conditions

Malignant Glioma

Keywords

Malignant GliomaGlioblastoma multiforme

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Survival rate of subjects measured up to 3 year after implantation

    Up to 3 years

Study Arms (1)

Cohort 1

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

Other: No intervention

Interventions

No interventionOTHER
Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosed malignant glioma treated by surgery

You may qualify if:

  • Malignant Glioma, patients enrolled in study GLI01S.

You may not qualify if:

  • Corresponding to contraindication of Gliadel.
  • Not applicable to indications of Gliadel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 35118382DERIVED

MeSH Terms

Conditions

GliomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

January 10, 2014

Primary Completion

July 10, 2016

Study Completion

July 10, 2016

Last Updated

November 5, 2018

Record last verified: 2017-08

Locations

JP(2)