Lung NeoplasmsNCT00639067
Breath Test for Early Detection of Lung Cancer
An observational study of Lung Neoplasms, run by Menssana Research, Inc. at 4 sites in United States.
Trial summary
To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Breath Collection Apparatus
- Type of treatment
- Medical device
- How many people
- 215 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Patient is willing and able to cooperate with study and give signed informed consent to participate.
Show all 17Show fewer
- 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.
- 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.
- Willingness to follow protocol requirements as evidenced by written, informed consent.
- Healthy, male or female subjects, ages 18 and older.
- Subjects who are non smokers having no signs or symptoms of lung carcinoma
Who cannot join
- 1. Previously documented history of cancer of any site.
- Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis
- 1. Previously documented history of cancer of any other site.
- Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis
- 1. Previously documented history of cancer of any other site.
- Group 4 - Apparently healthy subjects
- 1. Any active ongoing medical problems.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New York University Medical Center
New York, New York, 10016
Christiana Hospital
Newark, Delaware, 19718
MD Anderson Cancer Center
Orlando, Florida, 32806
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Neoplasms
- Being tested
- Breath Collection Apparatus
- Keywords
- Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Collection ApparatusDevice
Breath collected and analyzed for markers of lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT.
Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Breath Collection Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis.
Measured: 30 days after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menssana Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Phillips, MD, FACP, Principal investigator, Menssana Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639067
- Sponsor's protocol ID
- M08-01
- Other IDs
- 5R44HL070411-05
- Status last verified
- May 2014
- First submitted
- 12 Mar 2008
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31085817Phillips 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.
PubMed 26698306
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Test Assay for the Adjunctive Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT00639067
- Acronym / sponsor ID
- M08-01
- Conditions
- Lung Neoplasms
- Keywords
- Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Menssana Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Breath Collection ApparatusAsymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer. |
| 2 | – | Device: Breath Collection ApparatusSymptomatic 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. |
| 3 | – | Device: Breath Collection ApparatusSymptomatic 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. |
| 4 | – | Device: Breath Collection ApparatusApparently healthy individuals having no signs and symptoms of lung carcinoma. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (7 listed)
- 1. Previously documented history of cancer of any site.
- Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis
- 1. Previously documented history of cancer of any other site.
- Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis
- 1. Previously documented history of cancer of any other site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath Collection ApparatusBreath collected and analyzed for markers of lung cancer. | Device | 1, 2, 3, 4 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 31085817Phillips 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.
- Derived from this study: PubMed 26698306Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Phillips, MD, FACP principal investigator
Menssana Research, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Menssana Research, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639067, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.