Electronic Nose for Diagnosis of Neurodegenerative Diseas... | NCT01291550

Studies
Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

NCT01291550

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Feb 8, 2011Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Neurodegenerative Diseases

Interventions

Not provided

Countries

Israel

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 7, 2011

First Submission Date that Met QC Criteria

Feb 7, 2011

First Posted Date

Feb 8, 2011Estimated

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

Feb 7, 2011

Last Update Posted Date

Feb 8, 2011Estimated

Name	Class
Technion, Israel Institute of Technology	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 diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.

Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nerodegenerative diseases		Patients with parkinsonism and patients with dementia
Controls
ADHD		Subjects diagnosed with ADHD

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with neurodegenerative conditions
Healthy subjects
Subjects diagnosed with ADHD

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cognitive Neurology, Rambam Medical Center	Recruiting	Haifa		31096	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23067372	Derived	Tisch U, Schlesinger I, Ionescu R, Nassar M, Axelrod N, Robertman D, Tessler Y, Azar F, Marmur A, Aharon-Peretz J, Haick H. Detection of Alzheimer's and Parkinson's disease from exhaled breath using nanomaterial-based sensors. Nanomedicine (Lond). 2013 Jan;8(1):43-56. doi: 10.2217/nnm.12.105. Epub 2012 Oct 15.