NCT03876093

Brief Summary

Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor. The incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution. The main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

5.3 years

First QC Date

March 7, 2019

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of epileptic seizures

    number of epileptic seizures at the time of neurology consultation or hospitalization

    Day 1

Secondary Outcomes (1)

  • number of epileptic seizures

    until 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized following an epileptic seizure or seen in consultation in the neurology department of the GHPSJ, diagnosed with primary or secondary brain tumor from January 2013 to December 2023.

You may qualify if:

  • patient whose age ≥ 18 years
  • Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph
  • Diagnosis of primary or secondary brain tumor, radiologically and / or histologically
  • Epilepsy revealing or occurring in a patient developing a brain tumor
  • Francophone patient

You may not qualify if:

  • Pre-existing and known epilepsy before the diagnosis of brain tumors
  • Epilepsy occurring within 2 weeks postoperatively
  • Anteriority of taking antiepileptic treatment
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient with comprehension disorders making it impossible to understand the protocol
  • Patient or relative opposing the use of his data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Roubeau Vincent, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 15, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

April 27, 2021

Record last verified: 2021-04