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Exhaled Breath Biomarkers in Lung Cancer

This study is currently recruiting participants.
Verified February 2012 by Sheba Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386203
First Posted: June 30, 2011
Last Update Posted: February 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose

Analysis of volatile organic compounds (VOCs) is a new attractive non-invasive field in medical diagnostics. These VOCs can be detected via the exhaled breath.

Together with Prof Haick group at the Technion Inst (Israel), the investigators data shows that there is a relation between the VOCs patterns of NSCLC and control cell lines and equivalent states in exhaled breath. The investigators demonstrated that there is a clear discrimination between the lung cancer and the healthy clusters . The investigators also analyzed the headspace of NSCLC and SCLC cell lines and the investigators could discriminate significantly between SCLC versus NSCLC based on their VOCs patterns. This analysis allowed us to identify the specific VOCs consumed or omitted by cancerous cells. Therefore, a non-invasive and highly sensitive test would be extremely valuable for the classification and early screening of lung cancer and for targeted therapy. In this study, the investigators will monitor the VOC pattern of patients with lung cancer as well as high risk cohort and patients under risk/evaluation for lung cancer. Likewise the investigators will monitor pts under and after therapy. In addition, the investigators will compare teh breath signature to other biomarkers of lung cancer, like circulating tumor cells and others.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Detection of Lung Cancer - Exhaled Breath Nano-Analysis

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Biospecimen Retention:   Samples Without DNA
exhaled breath and CTC and biomarkers

Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lung Cancer
Lung Cancer after therapy
COPD controls

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung cancer patients vs. post therapy vs. COPD controls
Criteria

Inclusion Criteria

  • A diagnosis of lung cancer, regardless of histology.
  • A suspicious for lung cancer under investigation.
  • Able and willing to participate in this study
  • Availability of a signed informed consent

Exclusion Criteria

  • Inability to comply with study and/or follow up procedure
  • Inclusion of Women and Minorities
  • Both men and women and members of all races and ethnic groups are eligible for this study.
  • Criteria for discontinuation
  • Subjects may be discontinued from study treatment and assessments at any time.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386203


Contacts
Contact: Nir Peled, MD PhD peled.nir@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Nir Peled       peled.nir@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Nir Peled, MD PhD FCCP Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01386203     History of Changes
Other Study ID Numbers: SHEBA-11-8663-NP-CTIL
First Submitted: May 3, 2011
First Posted: June 30, 2011
Last Update Posted: February 29, 2012
Last Verified: February 2012

Keywords provided by Sheba Medical Center:
lung cancer
biomarkers
breath
early detection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases