Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01540552 |
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Recruitment Status :
Completed
First Posted : February 29, 2012
Last Update Posted : January 25, 2013
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer Precancerous Condition | Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
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 Type : | Observational |
| Actual Enrollment : | 320 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Budesonide Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
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Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
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Placebo Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
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Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
- Natural evolution of lung nodules [ Time Frame: 5 year review period ]
- Lung cancer detection rate [ Time Frame: 5 year review period ]
- Appearance of new nodules [ Time Frame: 5 year review period ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
DISEASE CHARACTERISTICS:
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Annual Computed Tomography (CT) scans obtained from participants with undetermined lung nodules detected by low-dose CT enrolled in both of the following trials:
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A large-scale COSMOS screening trial
- Three annual CT scans obtained as part of the COSMOS trial after budesonide study treatment completion
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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)
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- Only CT scans from participants enrolled in both trials will be used
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540552
| Italy | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Principal Investigator: | Powel H. Brown, MD, PhD | M.D. Anderson Cancer Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01540552 History of Changes |
| Other Study ID Numbers: |
PA11-1128 MDA-MDA05-5-03 CDR0000726610 ( Other Identifier: NCI Clinical Trials ) |
| First Posted: | February 29, 2012 Key Record Dates |
| Last Update Posted: | January 25, 2013 |
| Last Verified: | January 2013 |
Keywords provided by M.D. Anderson Cancer Center:
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lung cancer precancerous condition lung nodules CT Scan |
Additional relevant MeSH terms:
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Lung Neoplasms Precancerous Conditions Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Budesonide Anti-Inflammatory Agents |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |