Proof of Principle for a Diagnostic Blood Test of Recurre... | NCT02269397

Studies
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

NCT02269397

Sponsor

Cognizance Biomarkers, LLC

Status

Completed

Last Update Posted

Jul 31, 2019Actual

Enrollment

371Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013Actual

Primary Completion Date

Jul 14, 2015Actual

Completion Date

Dec 6, 2018Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Oct 16, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

Name	Class
University of Pennsylvania	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

371Actual

Label	Type	Description	Intervention Names
Individuals with suspected epilepsy		The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Peter Crino, MD, PhD	Cognizance Biomarkers, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Type	Date	Date Unknown
Release	Oct 28, 2019
Reset	Nov 15, 2019

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Apr 26, 2015	Jul 29, 2019	ICF_000.pdf
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 19, 2014	Jul 29, 2019	Prot_SAP_001.pdf

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 28, 2019			Nov 15, 2019

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures
D004194	Disease
D007249	Inflammation

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

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