NCT00639067

Brief Summary

To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

4.5 years

First QC Date

March 12, 2008

Last Update Submit

May 15, 2014

Conditions

Lung Neoplasms

Keywords

Cancer of LungCancer of the LungLung CancerNeoplasms, LungNeoplasms, PulmonaryPulmonary CancerPulmonary Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis.

    30 days after completion.

Study Arms (4)

1

Asymptomatic High Risk Subjects. Smokers aged \>=18 undergoing chest CT. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

Device: Breath Collection Apparatus

2

Symptomatic High Risk Subjects Without a Tissue Diagnosis. This group will comprise patients who are undergoing medical evaluation for a pulmonary symptom such as chronic unexplained cough or hemoptysis. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

Device: Breath Collection Apparatus

3

Symptomatic High Risk Subjects With a Tissue Diagnosis. This group will be found to include a. lung cancer, and b. diseases other than lung cancer e.g. sarcoidosis, COPD or pulmonary infection. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

Device: Breath Collection Apparatus

4

Apparently healthy individuals having no signs and symptoms of lung carcinoma. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

Device: Breath Collection Apparatus

Interventions

Breath Collection ApparatusDEVICE

Breath collected and analyzed for markers of lung cancer.

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group 1. Asymptomatic High Risk Subjects. Smokers aged \>=18 undergoing chest CT Group 2. Symptomatic High Risk Subjects Without a Tissue Diagnosis. This group will comprise patients who are undergoing medical evaluation for a pulmonary symptom such as chronic unexplained cough or hemoptysis. Group 3. Symptomatic High Risk Subjects With a Tissue Diagnosis. This group will be found to include a. lung cancer, and b. diseases other than lung cancer e.g. sarcoidosis, COPD or pulmonary infection. Group 4. Apparently healthy individuals having no signs and symptoms of lung carcinoma.

You may qualify if:

  • Patient is willing and able to cooperate with study and give signed informed consent to participate.
  • Patient has had (or will have) chest imaging with spiral CT within 7 days of breath test.
  • Age at least 18 years.
  • History of at least 10 pack-years of cigarette smoking.
  • Provide written informed consent prior to admission into the study.

You may not qualify if:

  • \. Previously documented history of cancer of any site.
  • Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis
  • Patient is willing and able to cooperate with study and give signed informed consent to participate.
  • Patient does not have a tissue diagnosis of pulmonary disease.
  • Patient is undergoing evaluation for an unexplained pulmonary illness which is clinically consistent with lung cancer. This includes patients with unexplained symptoms (e.g. chronic unexplained cough or hemoptysis), unexplained signs (e.g. weight loss, lymphadenopathy) or unexplained investigations (e.g. an abnormal chest x-ray).
  • Actively smoking patients, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded.
  • \. Previously documented history of cancer of any other site.
  • Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis
  • Patient is willing and able to cooperate with study and give signed informed consent to participate.
  • Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.
  • A diagnosis of lung cancer is defined as cytologic or histologic confirmation of lung cancer by bronchoscopic/thoracoscopic means, sputum cytology, percutaneous fine needle aspiration biopsy. Patients may have either non-small cell lung cancer or small cell lung cancer.
  • Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.
  • Actively smoking patients, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded.
  • \. Previously documented history of cancer of any other site.
  • Group 4 - Apparently healthy subjects
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MD Anderson Cancer Center

Orlando, Florida, 32806, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Phillips M, Bauer TL, Pass HI. A volatile biomarker in breath predicts lung cancer and pulmonary nodules. J Breath Res. 2019 Jun 19;13(3):036013. doi: 10.1088/1752-7163/ab21aa.

    PMID: 31085817DERIVED

  • Phillips M, Bauer TL, Cataneo RN, Lebauer C, Mundada M, Pass HI, Ramakrishna N, Rom WN, Vallieres E. Blinded Validation of Breath Biomarkers of Lung Cancer, a Potential Ancillary to Chest CT Screening. PLoS One. 2015 Dec 23;10(12):e0142484. doi: 10.1371/journal.pone.0142484. eCollection 2015.

    PMID: 26698306DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michael Phillips, MD, FACP

    Menssana Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

US(4)