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Exhaled Breath Biomarkers in Lung Cancer

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ClinicalTrials.gov Identifier: NCT01386203
Recruitment Status : Unknown
Verified February 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 30, 2011
Last Update Posted : February 29, 2012
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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 or disease
Lung Cancer

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Detection of Lung Cancer - Exhaled Breath Nano-Analysis
Study Start Date : June 2011
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Lung Cancer
Lung Cancer after therapy
COPD controls

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
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

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.

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

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

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Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Nir Peled       peled.nir@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Nir Peled, MD PhD FCCP Sheba Medical Center
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01386203    
Other Study ID Numbers: SHEBA-11-8663-NP-CTIL
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: February 29, 2012
Last Verified: February 2012
Keywords provided by Sheba Medical Center:
lung cancer
early detection
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases