High Risk of Developing Lung CancerNCT01700257
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
A study testing CT scan & Early CDT Lung test in people with High Risk of Developing Lung Cancer, run by National Jewish Health at 1 site in United States.
Trial summary
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- High Risk of Developing Lung Cancer
- What is being tested?
- CT scan & Early CDT Lung test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,361 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 7 Dec 2020
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers or former smokers
- At least 20 pack year history of smoking
- Ages 50 - 75
Who cannot join
- Had a CT scan of chest within last 24 months
- History of any cancer within 10 yrs (except skin cancer or cervical cancer)
- A serious illness that decreases life expectancy to less than 5 years
- Any current use of Oxygen
- Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
- Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.
Read the detailed description
In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.
- Conditions
- High Risk of Developing Lung Cancer
- Being tested
- CT scan & Early CDT Lung test
- Keywords
- Lung cancer screening, Smokers or former smokers, Family history of lung cancer
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan & Early CDT Lung testRadiation
Also called Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test), for lung cancer screening purposes
CT scan & Early CDT Lung testOther
Also called CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| CT scan & Early CDT Lung test | Other | Every study participant receives a CT scan \& Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes. Receives: Radiation: CT scan & Early CDT Lung test; Other: CT scan & Early CDT Lung test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT alone vs. both Early CDT-Lung test and CT scan.
Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
Measured: One year
Secondary outcomes (1)
Value of Early CDT-lung test in detecting cancer
Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startMay 2012
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk of Developing Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Jett, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700257
- Sponsor's protocol ID
- Oncimmune-2550
- Status last verified
- Dec 2020
- First submitted
- 2 Oct 2012
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT01700257
- Acronym / sponsor ID
- Oncimmune-2550
- Conditions
- High Risk of Developing Lung Cancer
- Keywords
- Lung cancer screening, Smokers or former smokers, Family history of lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,361 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 4 Oct 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.
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.
Detailed description
In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan & Early CDT Lung test | Other | Radiation: CT scan & Early CDT Lung test, Other: CT scan & Early CDT Lung testEvery study participant receives a CT scan \& Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smokers or former smokers
- At least 20 pack year history of smoking
- Ages 50 - 75
Key exclusion criteria (6 listed)
- Had a CT scan of chest within last 24 months
- History of any cancer within 10 yrs (except skin cancer or cervical cancer)
- A serious illness that decreases life expectancy to less than 5 years
- Any current use of Oxygen
- Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
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 |
|---|---|---|
| CT scan & Early CDT Lung testAlso: Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test), for lung cancer screening purposes | Radiation | CT scan & Early CDT Lung test |
| CT scan & Early CDT Lung testAlso: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening. | Other | CT scan & Early CDT Lung test |
Primary outcome
CT alone vs. both Early CDT-Lung test and CT scan.
Time frame: One year
Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
1 secondary outcome
Value of Early CDT-lung test in detecting cancer
Time frame: One year
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 31 Dec 2020.
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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.
James R Jett, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan & Early CDT Lung test in people with High Risk of Developing Lung Cancer, run by National Jewish Health 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 3 inclusion and 6 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 31 Dec 2020. 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?
CT alone vs. both Early CDT-Lung test and CT scan. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2020.