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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:
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
History of Changes
  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:

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
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
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:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
University of Texas MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

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
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013