Exhaled Breath Biomarkers in Lung Cancer
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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 |
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| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Nir Peled, MD PhD | peled.nir@sheba.health.gov.il |
| Israel | |
| Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel | |
| Contact: Nir Peled peled.nir@sheba.health.gov.il | |
| Principal Investigator: | Nir Peled, MD PhD FCCP | Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01386203 History of Changes |
| Other Study ID Numbers: | SHEBA-11-8663-NP-CTIL |
| Study First Received: | May 3, 2011 |
| Last Updated: | February 28, 2012 |
| Health Authority: | Israel: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on June 18, 2013