Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer

OBJECTIVES:

Primary

- Evaluation of lung nodules (target and non-target lesions) detected during annual
low-dose (ld) computed tomography (CT) scans and measured for three years after study
completion in subjects enrolled in a randomized, phase IIb, placebo-controlled trial
with inhaled budesonide (both person-specific and lesion-specific analyses will be
performed).

Secondary

- Lung cancer detection rate in the two arms.

- Appearance of new nodules in the two arms.

OUTLINE: Low-dose CT scans are analyzed retrospectively for the natural progression of
undetermined lung nodules. Nodule dimension will be evaluated according to maximum diameter
and volume, when feasible. Volume measurements are performed using an automatic and
semi-automatic computer-aided diagnosis (CAD) system. Lesion-specific and person-specific
analysis are performed by measure of average change in size of the target lesions or number
of lesions.

DISEASE CHARACTERISTICS:

- Annual CT scans obtained from participants with undetermined lung nodules detected by
low-dose CT enrolled in both of the following trials:

- A large-scale COSMOS screening trial

- Three annual CT scans obtained as part of the COSMOS trial after budesonide
study treatment completion

- The MDA05-5-01, a subset of COSMOS trial participants, a randomized phase II
trial of inhaled budesonide twice daily versus placebo

- Two CT scans performed as part of the budesonide protocol (MDA05-5-01)

- Only CT scans from participants enrolled in both trials will be used

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics