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
  Purpose

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


Condition Intervention
Lung Neoplasms
Device: Breath Collection Apparatus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breath Test Assay for the Adjunctive Detection of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Menssana Research, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 215
Study Start Date: June 2008
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Breath collected and analyzed for markers of lung cancer.
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
Breath collected and analyzed for markers of lung cancer.
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
Breath collected and analyzed for markers of lung cancer.
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
Breath collected and analyzed for markers of lung cancer.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

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.

  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: NCT00639067

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
United States, New York
New York University Medical Center
New York, New York, United States, 10016
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Menssana Research, Inc.
Investigators
Principal Investigator: Michael Phillips, MD, FACP Menssana Research, Inc.
  More Information

No publications provided

Responsible Party: Menssana Research, Inc.
ClinicalTrials.gov Identifier: NCT00639067     History of Changes
Other Study ID Numbers: M08-01, 5R44HL070411-05
Study First Received: March 12, 2008
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Menssana Research, Inc.:
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014