Lung CancerNCT01663155
Chest Imaging, Breath, and Biomarkers in a Screening Trial
An observational study of Lung Cancer, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- chest x-ray with or without CAD, lose dose CT scan
- Type of treatment
- Medical device
- How many people
- 1,424 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to May 2014
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care physicians or any other physician may refer potential candidates. Additionally, subjects may see marketing materials and contact the research team directly. There is no restriction to the area of residence of subjects.
Who may be able to join
- ages 40-75 years
- If ages 40-59, then one of the following criteria needs to be met:
- Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR
- current or ex-smoker with > 25 pack years and COPD OR
- current or ex-smoker with a > 35 pack year history
- If ages 60-75, then one of the following additional criteria needs to be met:
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- Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR
- Current or ex-smoker with >25 pack years and COPD OR
- Current or ex-smoker with a >30 pack year history
- Subject is able to return to Cleveland Clinic for annual follow-up screening
- Subject is willing to sign a medical release form
Who cannot join
- Current health requires oxygen
- Have had a chest x-ray or CT of the chest within the last 6 months
- Previous pneumonectomy
- Lobectomy of the lung within the last 5 years
- Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer
- A medical condition that would prevent treatment for lung cancer
Show all 13Show fewer
- Within the last 6 weeks, one of the following has occured:
- A new cough or chronic cough that has gotten worse
- Either new shortness of breath, or any worsening of shortness of breath
- A cough producing blood
- Constant chest pain
- Respiratory infection, pneumonia, or cold
- Unintentional and unexplained weight loss greater than 5% of total body weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.
Read the detailed description
The fight against lung cancer is waged on three major fronts: prevention, detection and treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective. If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.
- Conditions
- Lung Cancer
- Being tested
- chest x-ray with or without CAD, lose dose CT scan
- Keywords
- lung cancer, chest x-ray, CT scan, computer aided detection (CAD), screening, smokers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest x-ray with or without CAD, lose dose CT scanDevice
Also called CAD, computer aided detection
PA view, low dose CT scan
| Study group | Role | What they receive |
|---|---|---|
| all enrolled subjects | Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples. Receives: Device: chest x-ray with or without CAD, lose dose CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivities of chest x-ray with CAD and chest CT
The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.
Measured: One year after scan
Secondary outcomes (5)
Disease-specific mortality between screening with chest x-ray and CAD versus no screening
Mortality rate in screening x-ray vs CAD
Measured: One year after scan
All-cause mortality rate between screening with chest x-ray and CAD versus no screening
All cause mortality rate
Measured: One year after scan
Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls
Time between randomization and symptom
Measured: One year after scan
Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population
Cancer detection rate between chest x-ray and CAD
Measured: One year after scan
The quality of life between screening with chest x-ray and CAD versus no screening.
Quality of life between the chest x-ray group and the CAD group
Measured: One year after scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startSep 2008
- Primary completionMay 2014
- Study completionMay 2014
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 CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 1,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moulay Meziane, MD, The Cleveland Clinic
- Investigators
- Micheal Phillips, M.D., Study chair, The Cleveland ClinicMoulay Meziane, MD, Principal investigator, Chair of Thoracic Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663155
- Sponsor's protocol ID
- 07-455
- Other IDs
- State of Ohio grant, 06-055
- Status last verified
- May 2017
- First submitted
- 10 Nov 2008
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC.
PubMed 23952850Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20.
PubMed 23527241
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
- ClinicalTrials.gov ID
- NCT01663155
- Acronym / sponsor ID
- 07-455
- Conditions
- Lung Cancer
- Keywords
- lung cancer, chest x-ray, CT scan, computer aided detection (CAD), screening, smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,424 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Aug 2012 (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.
The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.
Detailed description
The fight against lung cancer is waged on three major fronts: prevention, detection and treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective. If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all enrolled subjects | – | Device: chest x-ray with or without CAD, lose dose CT scanIntervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care physicians or any other physician may refer potential candidates. Additionally, subjects may see marketing materials and contact the research team directly. There is no restriction to the area of residence of subjects.
Key inclusion criteria (11 listed)
- ages 40-75 years
- If ages 40-59, then one of the following criteria needs to be met:
- If ages 60-75, then one of the following additional criteria needs to be met:
- Subject is able to return to Cleveland Clinic for annual follow-up screening
- Subject is willing to sign a medical release form
Key exclusion criteria (13 listed)
- Current health requires oxygen
- Have had a chest x-ray or CT of the chest within the last 6 months
- Previous pneumonectomy
- Lobectomy of the lung within the last 5 years
- Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer
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 |
|---|---|---|
| chest x-ray with or without CAD, lose dose CT scanAlso: CAD, computer aided detectionPA view, low dose CT scan | Device | all enrolled subjects |
Primary outcome
The sensitivities of chest x-ray with CAD and chest CT
Time frame: One year after scan
The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.
5 secondary outcomes
Disease-specific mortality between screening with chest x-ray and CAD versus no screening
Time frame: One year after scan
All-cause mortality rate between screening with chest x-ray and CAD versus no screening
Time frame: One year after scan
Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls
Time frame: One year after scan
Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population
Time frame: One year after scan
The quality of life between screening with chest x-ray and CAD versus no screening.
Time frame: One year after scan
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 18 May 2017.
- Derived from this study: PubMed 23952850Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC.
- Derived from this study: PubMed 23527241Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20.
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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.
Micheal Phillips, M.D. study chair
The Cleveland Clinic
Moulay Meziane, MD principal investigator
Chair of Thoracic Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by The Cleveland Clinic at 1 site 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 11 inclusion and 13 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The sensitivities of chest x-ray with CAD and chest CT (time frame: One year after scan). 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 NCT01663155, 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 18 May 2017.