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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide

Conditions
-----------------
Lung Cancer, Precancerous Condition

Intervention / Treatment
-----------------
* Other: medical chart review
* Procedure: computed tomography
* Procedure: computer-aided detection/diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Budesonide Arm<br>Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide. | Other: medical chart review<br> <br> Procedure: computed tomography<br> <br> Procedure: computer-aided detection/diagnosis<br> <br> |
| Placebo Arm<br>Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo. | Other: medical chart review<br> <br> Procedure: computed tomography<br> <br> Procedure: computer-aided detection/diagnosis<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural evolution of lung nodules |  | 5 year review period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer detection rate |  | 5 year review period | 
| Appearance of new nodules |  | 5 year review period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, precancerous condition, lung nodules, CT Scan