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

• Conditions: Pancreatic Cancer

• Registration Number: NCT01994681
• Lead Sponsor: Rauscher, Gregory E., M.D. PA

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 available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-26
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05
• Primary Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States