Trial record 4 of 31 for:    pancreatic,cancer,detection | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rauscher, Gregory E., M.D. PA
Sponsor:
Collaborator:
Spectrosense Ltd.
Information provided by (Responsible Party):
Rauscher, Gregory E., M.D. PA
ClinicalTrials.gov Identifier:
NCT01994681
First received: November 20, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Resource links provided by NLM:


Further study details as provided by Rauscher, Gregory E., M.D. PA:

Primary Outcome Measures:
  • Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    An optimization algorithm will select VOCs that will provide maximal sensitivity and specificity.


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cancer
Healthy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994681

Contacts
Contact: Kevin Barga (551)996-8017 kbarga@hackensackumc.org

Locations
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Rauscher, Gregory E., M.D. PA
Spectrosense Ltd.
Investigators
Principal Investigator: Martin Gutierrez, MD Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Rauscher, Gregory E., M.D. PA
ClinicalTrials.gov Identifier: NCT01994681     History of Changes
Other Study ID Numbers: 00004108
Study First Received: November 20, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014