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

Completed

• Conditions: Lung Cancer; Precancerous Condition
• Interventions: Other: medical chart review; Procedure: computed tomography; Procedure: computer-aided detection/diagnosis

• Registration Number: NCT01540552
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-29
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Budesonide Arm	medical chart review	Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
Budesonide Arm	computed tomography	Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
Budesonide Arm	computer-aided detection/diagnosis	Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
Placebo Arm	medical chart review	Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
Placebo Arm	computed tomography	Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
Placebo Arm	computer-aided detection/diagnosis	Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.

Primary Outcome Measures

Name	Time	Method
Natural evolution of lung nodules	5 year review period

Secondary Outcome Measures

Name	Time	Method
Lung cancer detection rate	5 year review period
Appearance of new nodules	5 year review period

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy