Full Text View
Tabular View
No Study Results Posted
Related Studies
Breath Test for Early Detection of Lung Cancer
This study is currently recruiting participants.
Verified by Menssana Research, Inc., July 2009
First Received: March 12, 2008   Last Updated: July 31, 2009   History of Changes
Sponsored by: Menssana Research, Inc.
Information provided by: Menssana Research, Inc.
ClinicalTrials.gov Identifier: NCT00639067
  Purpose

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


Condition
Lung Neoplasms

Study Type: Observational
Study Design: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 600
Study Start Date: June 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT
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.
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.
4
Apparently healthy individuals having no signs and symptoms of lung carcinoma.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639067

Locations
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Thomas Bauer     302-623-4530     TBauer@Christianacare.org    
Principal Investigator: Thomas Bauer, MD            
United States, Florida
MD Anderson Cancer Center Recruiting
Orlando, Florida, United States, 32806
Contact: Alan R Forbes, MD, PhD     407-648-3800     Alan.Forbes@orhs.org    
Principal Investigator: Alan R Forbes, MD, PhD            
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Matthew Cham, MD     212-746-6880        
Principal Investigator: Matthew Cham, MD            
Sub-Investigator: David F Yankelevitz, MD            
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: William N Rom, MD, MPH     212-263-6479     william.rom@med.nyu.edu    
Principal Investigator: Harvey I Pass, MD            
Sub-Investigator: William N Rom, MD, MPH            
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Eric Vallieres, MD, FRCSC     206-215-6800     Eric.Vallieres@swedish.org    
Principal Investigator: Eric Vallieres, MD, FRCSC            
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. ( Michael Phillips/Sponsor )
Study ID Numbers: M01-08, NIH 5R44HL070411-05
Study First Received: March 12, 2008
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00639067     History of Changes
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

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

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

ClinicalTrials.gov processed this record on September 10, 2009