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

• Lung cancer detection rate [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]
• Appearance of new nodules [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]

• Lung cancer detection rate [ Designated as safety issue: No ]
• Appearance of new nodules [ Designated as safety issue: No ]

RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for 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.

Participants previously enrolled in two trials: (1) a large scale COSMOS trial and (2) a subset of the COSMOS trial (MDA05-5-01 Budesonide study and treated for one year). Only participants enrolled in both trials will be included.

• Lung Cancer
• Precancerous Condition

• Other: medical chart review
• Procedure: computed tomography
• Procedure: computer-aided detection/diagnosis

• Budesonide Arm
  Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
  Interventions:

  • Other: medical chart review
  • Procedure: computed tomography
  • Procedure: computer-aided detection/diagnosis
• Placebo Arm
  Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
  Interventions:

  • Other: medical chart review
  • Procedure: computed tomography
  • Procedure: computer-aided detection/diagnosis

DISEASE CHARACTERISTICS:

• Annual Computed Tomography (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