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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540552
• Other study ID #: PA11-1128
• Secondary ID: MDA-MDA05-5-03CD
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: January 24, 2013
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• medical chart review

Procedure:
• computed tomography

• computer-aided detection/diagnosis

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural evolution of lung nodules		5 year review period	No
Secondary	Lung cancer detection rate		5 year review period	No
Secondary	Appearance of new nodules		5 year review period	No

External Links

•   University of Texas MD Anderson Cancer Center