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| ID | Type | Description | Link |
|---|---|---|---|
| MDA-MDA05-5-03 | |||
| CDR0000726610 | Other Identifier | NCI Clinical Trials |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide Arm | Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide. |
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| Placebo Arm | Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical chart review | Other |
| ||
| computed tomography |
| Measure | Description | Time Frame |
|---|---|---|
| Natural evolution of lung nodules | 5 year review period |
| Measure | Description | Time Frame |
|---|---|---|
| Lung cancer detection rate | 5 year review period | |
| Appearance of new nodules | 5 year review period |
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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
The MDA05-5-01, a subset of COSMOS trial participants, a randomized phase II trial of inhaled budesonide twice daily versus placebo
Only CT scans from participants enrolled in both trials will be used
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Powel H. Brown, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25672894 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003936 | Diagnosis, Computer-Assisted |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
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| Procedure |
|
| computer-aided detection/diagnosis | Procedure |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |