EpilepsyNCT02269397
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
An observational study of Epilepsy, run by Cognizance Biomarkers, LLC at 1 site in United States.
Trial summary
The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 6 Dec 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects aged 12 years and older who are attending their first visit to the University of Pennsylvania's Epilepsy Center for diagnostic purposes
Who may be able to join
- Male/female patients aged 12 and older
- Evaluation in at least one of the following settings:
- Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites
- All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring
Who cannot join
- Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf
- Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizures, Diagnosis, Diagnostic, Inflammation
- Medical subject headings
- Epilepsy, Seizures, Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with suspected epilepsy | The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis
Epilepsy diagnosis determined by three epileptologist's review of subject's medical records
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJul 2013
- Primary completion14 Jul 2015
- Study completion6 Dec 2018
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
- Prospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognizance Biomarkers, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Peter Crino, MD, PhD, Study director, Cognizance Biomarkers, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269397
- Sponsor's protocol ID
- 817914
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2013
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
- ClinicalTrials.gov ID
- NCT02269397
- Acronym / sponsor ID
- 817914
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizures, Diagnosis, Diagnostic, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Cognizance Biomarkers, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- Jul 2013 (actual)
- Primary completion
- 14 Jul 2015 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with suspected epilepsy | – | –The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects aged 12 years and older who are attending their first visit to the University of Pennsylvania's Epilepsy Center for diagnostic purposes
Key inclusion criteria (4 listed)
- Male/female patients aged 12 and older
- Evaluation in at least one of the following settings:
- Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites
- All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring
Key exclusion criteria (2 listed)
- Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf
- Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason
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
Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis
Time frame: 2 years
Epilepsy diagnosis determined by three epileptologist's review of subject's medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Peter Crino, MD, PhD study director
Cognizance Biomarkers, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Cognizance Biomarkers, LLC at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis (time frame: 2 years). 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 31 Jul 2019.