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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
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment
Lung Cancer Precancerous Condition 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.


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

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Natural evolution of lung nodules [ Time Frame: 5 year review period ]

Secondary Outcome Measures :
  1. Lung cancer detection rate [ Time Frame: 5 year review period ]
  2. Appearance of new nodules [ Time Frame: 5 year review period ]


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

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


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

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:
lung cancer
precancerous condition
lung nodules
CT Scan

Additional relevant MeSH terms:
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