Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
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

February 22, 2012
January 24, 2013
February 2012
January 2013   (final data collection date for primary outcome measure)
Natural evolution of lung nodules [ Time Frame: 5 year review period ] [ Designated as safety issue: No ]
Natural evolution of lung nodules [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01540552 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lung cancer detection rate [ Designated as safety issue: No ]
  • Appearance of new nodules [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide

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

  • 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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Lung Cancer
  • Precancerous Condition
  • Other: medical chart review
  • Procedure: computed tomography
  • Procedure: computer-aided detection/diagnosis
  • Budesonide Arm
    Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
    Interventions:
    • 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.
    Interventions:
    • Other: medical chart review
    • Procedure: computed tomography
    • Procedure: computer-aided detection/diagnosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01540552
PA11-1128, MDA-MDA05-5-03, CDR0000726610
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Powel H. Brown, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP