NCT01386203

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2011

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 29, 2012

Status Verified

February 1, 2012

Enrollment Period

4.9 years

First QC Date

May 3, 2011

Last Update Submit

February 28, 2012

Conditions

Keywords

lung cancerbiomarkersbreathearly detection

Study Arms (3)

Lung Cancer

Lung Cancer after therapy

COPD controls

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath and CTC and biomarkers

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nir Peled, MD PhD FCCP

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Peled, MD PhD

CONTACT

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

Locations