Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

NCT02269397 | Completed

• 1 other identifier: 817914
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

Individuals with suspected epilepsy

The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognizance Biomarkers, LLC: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subjects will be asked to give blood for evaluation of a diagnostic blood test for epilepsy

MeSH Terms

Conditions

Epilepsy; Seizures; Disease; Inflammation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Peter Crino, MD, PhD

  Cognizance Biomarkers, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: October 21, 2014
• Study Start: July 1, 2013
• Primary Completion: July 14, 2015
• Study Completion: December 6, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)