COPDGene/Lung Cancer Center Database

COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung
Cancer Database:

1. The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire.

2. The COPDGene® Phase 2 Medical History Questionnaire at Visit 1

3. 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.

Inclusion Criteria:

- Subjects must meet all of the following criteria

1. 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).

2. Documented GOLD stage 1-4 COPD or a history of smoking with no COPD

3. 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