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Epilepsy-related Brain Tumors Register

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ClinicalTrials.gov Identifier: NCT03876093
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Tracking Information
First Submitted Date March 7, 2019
First Posted Date March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2019)
number of epileptic seizures [ Time Frame: Day 1 ]
number of epileptic seizures at the time of neurology consultation or hospitalization
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 13, 2019)
number of epileptic seizures [ Time Frame: until 10 years ]
number of epileptic seizures at every visit
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epilepsy-related Brain Tumors Register
Official Title Epilepsy-related Brain Tumors Register
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 13, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Roubeau Vincent, MD 0144127750 vroubeau@hpsj.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03876093
Other Study ID Numbers Epilepsy-related brain tumors
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Roubeau Vincent, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date March 2019