Breath Test for Early Detection of Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Menssana Research, Inc.
ClinicalTrials.gov Identifier:
NCT00639067
First received: March 12, 2008
Last updated: May 15, 2014
Last verified: May 2014

March 12, 2008
May 15, 2014
June 2008
December 2012   (final data collection date for primary outcome measure)
Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis. [ Time Frame: 30 days after completion. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639067 on ClinicalTrials.gov Archive Site
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Not Provided
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Breath Test for Early Detection of Lung Cancer
Breath Test Assay for the Adjunctive Detection of Lung Cancer

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

This is a multicenter study comparing several groups of subjects with and without lung cancer by CT scan, biopsy and the breath test. The breath test will be performed to validate the methodology and the predictive algorithm that were previously developed.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

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.

Lung Neoplasms
Device: Breath Collection Apparatus
Breath collected and analyzed for markers of lung cancer.
  • 1

    Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT.

    Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

    Intervention: 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.

    Intervention: 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.

    Intervention: 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.

    Intervention: Device: Breath Collection Apparatus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
December 2013
December 2012   (final data collection date for primary outcome measure)

Group 1 - Asymptomatic High Risk Subjects

Inclusion criteria

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

Exclusion criteria

1. Previously documented history of cancer of any site.

Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis

Inclusion criteria

  1. Patient is willing and able to cooperate with study and give signed informed consent to participate.
  2. Patient does not have a tissue diagnosis of pulmonary disease.
  3. 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).
  4. 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.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis

Inclusion criteria

  1. Patient is willing and able to cooperate with study and give signed informed consent to participate.
  2. Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.
  3. 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.
  4. Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.
  5. 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.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 4 - Apparently healthy subjects

Inclusion criteria

  1. Willingness to follow protocol requirements as evidenced by written, informed consent.
  2. Healthy, male or female subjects, ages 18 and older.
  3. Subjects who are non smokers having no signs or symptoms of lung carcinoma

Exclusion Criteria

1. Any active ongoing medical problems.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639067
M08-01, 5R44HL070411-05
No
Menssana Research, Inc.
Menssana Research, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael Phillips, MD, FACP Menssana Research, Inc.
Menssana Research, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP