COPDGene/Lung Cancer Center Database

Study Overview
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Brief Summary
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The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene® Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.

Detailed Description
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COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung Cancer Database: The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire. The COPDGene® Phase 2 Medical History Questionnaire at Visit 1 Medical Records Collection through the Mortality Adjudication Committee Potential cases will be those who respond yes to lung cancer will be contacted by phone by a study coordinator and be screened for the COPDGene® Lung Cancer Database. Medical records will be analyzed to determine the patient's cancer diagnosis, pathology, and treatment. Information will be collected at each individual institution, de-identified, and entered into the password-protected COPDGene® DCC lung cancer database, through a web-based interface. The survival data will be obtained through review of medical records or the Social Security Death Index in conjunction with the COPDGene® mortality adjudication committee. For the nested case-control study, controls will be matched from the those subjects on COPDGene who answered 'No' to the longitudinal follow-up question have you been diagnosed with lung cancer as per COPDGene protocol. Medical records regarding the patient's cancer diagnosis, pathology and treatment will be collected following signed release of medical information from the patient. The following information will be collected and entered into a database. The survival data will be obtained through review of medical records or the Social Security Death Index. i. Date of diagnosis ii. Type of specimen iii. Laterality iv. Lobe v. Record of any false positives (can be used as verified controls) b. Pathology Findings: i. Histology ii. Molecular Analysis, if done. iii. Stage (TNM classification) iv. Histologic grade c. Treatment i. Surgery ii. Radiation iii. Chemotherapy iv. Presentation at Tumor Board d. Outcomes i. Recurrence, Second primary cancers ii. Survival after cancer diagnosis, Cause of death Study coordinators at each site contact subjects who have self-reported lung cancer or were identified as having lung cancer by follow-up clinic visits and complete the lung cancer data form. The data collected on each subject is de-identified at the recruiting site prior to being downloaded into the COPDGene® DCC located at National Jewish Health. A lung cancer adjudication committee, including Drs. Carr and Bowler, will review each case for accuracy and completeness.

Official Title
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COPDGene/Lung Cancer Center Database

Conditions
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Lung Cancer, COPD

Intervention / Treatment
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* Other: None, N/A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria Be enrolled in COPDGene® Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC). Documented GOLD stage 1-4 COPD or a history of smoking with no COPD Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer<br>Confirmed diagnosis of lung cancer | Other: None, N/A<br> <br> |
| No Lung Cancer Controls<br>Unconfirmed lung cancer diagnosis, false positive | Other: None, N/A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify lung cancer variables | Use existing COPDGene® quantitative HRCT and clinical data to perform a nested case-control study and perform a univariate analysis to select significant variables for the development of lung cancer. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of lung cancer based on variables | Construct a multivariate model from the results of the univariate analysis to calculate the odds ratios for the variables that predict lung cancer | 1.5 years |