Pancreatic Cancer Clinical Trial
Official title:
Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
| NCT number | NCT01994681 |
| Other study ID # | 00004108 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | November 20, 2013 |
| Last updated | December 4, 2013 |
| Start date | October 2013 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rauscher, Gregory E., M.D. PA | Spectrosense Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
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