NCT02300532

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
561

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2014

Completed
4 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
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2015

Completed
Last Updated

February 27, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

November 21, 2014

Last Update Submit

February 23, 2017

Conditions

Malignant Glioma

Keywords

Malignant GliomaGlioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events/Serious Adverse Events

    Up to 3 months

Secondary Outcomes (1)

  • Survival rate

    Up to 1 year

Study Arms (1)

Cohort 1

Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg

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:

  • All-patient of Gliadel implantation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Tokyo, Tokyo, Japan

Location

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, 2013

Primary Completion

July 10, 2014

Study Completion

March 24, 2015

Last Updated

February 27, 2017

Record last verified: 2017-01

Locations

JP(2)