Testing Spectrosense EVA System for Detection of Breast C... | NCT01849328

Studies
Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

NCT01849328

Sponsor

Rauscher, Gregory E., M.D. PA

Status

Unknown status

Last Update Posted

Nov 19, 2013Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Breast Cancer

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

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

Nov 2013

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

May 2013

Primary Completion Date

May 2014Estimated

Completion Date

Not provided

First Submitted Date

May 3, 2013

First Submission Date that Met QC Criteria

May 5, 2013

First Posted Date

May 8, 2013Estimated

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

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

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

Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven breast cancer.

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

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. breast cancer.		Upon enrollment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Breast Cancer group:

Inclusion Criteria:

Age from 18 years old
Breast cancer positive biopsy
Before any treatment
Signed Informed Patient Consent

Exclusion Criteria:

Age under 18 years old
Neoadjovant treatment
Post surgery for breast cancer
A history of any other cancer type, except skin cancer that is not melanoma

Healthy group:

Inclusion Criteria:

Healthy women
No history of Breast cancer
Signed Informed Patient Consent

Exclusion Criteria:

History of Breast cancer
Breast cancer background in the family
A history of any other cancer type, except skin cancer that is not melanoma

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with breast cancer, biopsy confirmed, ages above 18. vs. Healthy women without breast cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jamie Ketas	Contact	201-894-3418		Jamie.Ketas@ehmc.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Englewood Hospital and Medical Center	Recruiting	Englewood	New Jersey	07631	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided