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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
High Risk of Developing Lung Cancer |
Radiation: CT scan & Early CDT Lung test Other: CT scan & Early CDT Lung test |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Jewish Health:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
Other Outcome Measures:
- 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.
| Estimated Enrollment: | 1600 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Radiation: CT scan & Early CDT Lung test
Other Names:
Other: CT scan & Early CDT Lung test
Other Name: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Smokers or former smokers
- At least 20 pack year history of smoking
- Ages 50 - 75
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700257
Contacts
| Contact: Nina Thompson, BS | 303-270-2564 | thompsonn@njhealth.org |
| Contact: Melanie Phillips, BS | 303-398-1921 | phillipsm@njhealth.org |
Locations
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Nina Thompson, BS 303-270-2564 thompsonn@njhealth.org | |
| Contact: Melanie Phillips, BS 303-398-1921 phillipsm@njhealth.org | |
| Principal Investigator: Jim Jett, MD | |
Sponsors and Collaborators
National Jewish Health
Investigators
| Principal Investigator: | Jim Jett, MD | National Jewish Health |
More Information
No publications provided
| Responsible Party: | National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT01700257 History of Changes |
| Other Study ID Numbers: | Oncimmune-2550 |
| Study First Received: | October 2, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by National Jewish Health:
|
Lung cancer screening Smokers or former smokers Family history of lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013