EpilepsyNCT03876093
Epilepsy-related Brain Tumors Register
An observational study of Epilepsy, run by Fondation Hôpital Saint-Joseph.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
number of epileptic seizures
number of epileptic seizures at the time of neurology consultation or hospitalization
Measured: Day 1
Secondary outcomes (1)
number of epileptic seizures
number of epileptic seizures at every visit
Measured: until 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: The PI decided.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roubeau Vincent, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876093
- Sponsor's protocol ID
- Epilepsy-related brain tumors
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy-related Brain Tumors Register
- ClinicalTrials.gov ID
- NCT03876093
- Acronym / sponsor ID
- Epilepsy-related brain tumors
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The PI decided.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of epileptic seizures
Time frame: Day 1
number of epileptic seizures at the time of neurology consultation or hospitalization
1 secondary outcome
number of epileptic seizures
Time frame: until 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roubeau Vincent, MD principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Fondation Hôpital Saint-Joseph.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of epileptic seizures (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.