About this trial
Last updated 4 years ago
Study ID
HS 2815
Status
Completed
Type
Observational [Patient Registry]
Placebo
No
Accepting
40+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 5 years ago
What is this trial about?
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.
What are the participation requirements?
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