Exhaled Breath Biomarkers in Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01386203
First received: May 3, 2011
Last updated: February 28, 2012
Last verified: February 2012
  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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
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: 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

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 September 18, 2014