Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
NCT ID: NCT01540552
Last Updated: 2013-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
320 participants
OBSERVATIONAL
2012-02-29
2013-01-31
Brief Summary
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PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Budesonide Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
medical chart review
computed tomography
computer-aided detection/diagnosis
Placebo Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
medical chart review
computed tomography
computer-aided detection/diagnosis
Interventions
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medical chart review
computed tomography
computer-aided detection/diagnosis
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Powel H. Brown, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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European Institute of Oncology
Milan, , Italy
Countries
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References
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Veronesi G, Lazzeroni M, Szabo E, Brown PH, DeCensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Grimaldi MC, Spaggiari L, Bonanni B. Long-term effects of inhaled budesonide on screening-detected lung nodules. Ann Oncol. 2015 May;26(5):1025-1030. doi: 10.1093/annonc/mdv064. Epub 2015 Feb 11.
Related Links
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University of Texas MD Anderson Cancer Center
Other Identifiers
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MDA-MDA05-5-03
Identifier Type: -
Identifier Source: secondary_id
CDR0000726610
Identifier Type: OTHER
Identifier Source: secondary_id
PA11-1128
Identifier Type: -
Identifier Source: org_study_id
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