Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01540552
First received: February 22, 2012
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Lung Cancer Precancerous Condition |
Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
Drug Information available for:
Budesonide
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Natural evolution of lung nodules [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Lung cancer detection rate [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]
- Appearance of new nodules [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]
| Enrollment: | 320 |
| Study Start Date: | February 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Budesonide Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
|
Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
|
Placebo Arm
Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
|
Other: medical chart review Procedure: computed tomography Procedure: computer-aided detection/diagnosis |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540552
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540552
Locations
| Italy | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Powel H. Brown, MD, PhD | M.D. Anderson Cancer Center |
More Information
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 |
| Study First Received: | February 22, 2012 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
lung cancer precancerous condition lung nodules CT Scan |
Additional relevant MeSH terms:
|
Lung Neoplasms Disease Precancerous Conditions Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pathologic Processes 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 |
ClinicalTrials.gov processed this record on September 27, 2016