Exhaled Breath Biomarkers in Lung Cancer
Early Detection of Lung Cancer - Exhaled Breath Nano-Analysis
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFebruary 29, 2012
February 1, 2012
4.9 years
May 3, 2011
February 28, 2012
Conditions
Keywords
Study Arms (3)
Lung Cancer
Lung Cancer after therapy
COPD controls
Eligibility Criteria
Lung cancer patients vs. post therapy vs. COPD controls
You may qualify if:
- 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
You may not qualify if:
- Inability to comply with study and/or follow up procedure
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, Israel
Biospecimen
exhaled breath and CTC and biomarkers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nir Peled, MD PhD FCCP
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
May 1, 2016
Study Completion
May 1, 2018
Last Updated
February 29, 2012
Record last verified: 2012-02