Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
This study is currently recruiting participants.
Verified April 2013 by National Jewish Health
Sponsor:
National Jewish Health
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01700257
First received: October 2, 2012
Last updated: April 30, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 2, 2012 | ||||||||
| Last Updated Date | April 30, 2013 | ||||||||
| Start Date ICMJE | May 2012 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
CT alone vs. both Early CDT-Lung test and CT scan. [ Time Frame: One year ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01700257 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Value of Early CDT-lung test in detecting cancer [ Time Frame: One year ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
Health Economics [ Time Frame: One Year ] [ Designated as safety issue: No ] Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker | ||||||||
| Official Title ICMJE | Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | High Risk of Developing Lung Cancer | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | CT scan & Early CDT Lung test
Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1600 | ||||||||
| Estimated Completion Date | May 2016 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01700257 | ||||||||
| Other Study ID Numbers ICMJE | Oncimmune-2550 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | National Jewish Health | ||||||||
| Study Sponsor ICMJE | National Jewish Health | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Jewish Health | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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