Testing Spectrosense EVA System for Detection of Pancreat... | NCT01994681

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

NCT01994681

Sponsor

Rauscher, Gregory E., M.D. PA

Status

Unknown status

Last Update Posted

Dec 5, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Pancreatic 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

Dec 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

Oct 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Not provided

First Submitted Date

Nov 20, 2013

First Submission Date that Met QC Criteria

Nov 20, 2013

First Posted Date

Nov 26, 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

Dec 4, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Name	Class
Spectrosense Ltd.	INDUSTRY

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 Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic 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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population.	An optimization algorithm will select VOCs that will provide maximal sensitivity and specificity.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Pancreatic cancer Group

Inclusion Criteria:

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

Exclusion Criteria:

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

Healthy Group

Inclusion Criteria:

Healthy patients
No history of Pancreatic cancer
Signed Informed Patient Consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with pancreatic cancer, biopsy confirmed, before treatment, ages above 18. vs. Healthy subjects without pancreatic cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kevin Barga	Contact	(551)996-8017		kbarga@hackensackumc.org

Overall Officials

Name	Affiliation	Role
Martin Gutierrez, MD	Hackensack Meridian Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hackensack University Medical Center	Recruiting	Hackensack	New Jersey	07601	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided