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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

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.


Condition or disease
Epilepsy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epilepsy-related Brain Tumors Register
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. number of epileptic seizures [ Time Frame: Day 1 ]
    number of epileptic seizures at the time of neurology consultation or hospitalization


Secondary Outcome Measures :
  1. number of epileptic seizures [ Time Frame: until 10 years ]
    number of epileptic seizures at every visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876093


Contacts
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Contact: Roubeau Vincent, MD 0144127750 vroubeau@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Groupe Hospitalier P Saint-Joseph    144127038    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Roubeau Vincent, MD Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03876093     History of Changes
Other Study ID Numbers: Epilepsy-related brain tumors
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epilepsy
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms