NCT01540552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

February 22, 2012

Last Update Submit

January 24, 2013

Conditions

Lung CancerPrecancerous Condition

Keywords

lung cancerprecancerous conditionlung nodulesCT Scan

Outcome Measures

Primary Outcomes (1)

  • Natural evolution of lung nodules

    5 year review period

Secondary Outcomes (2)

  • Lung cancer detection rate

    5 year review period

  • Appearance of new nodules

    5 year review period

Study Arms (2)

Budesonide Arm

Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.

Other: medical chart reviewProcedure: computed tomographyProcedure: computer-aided detection/diagnosis

Placebo Arm

Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.

Other: medical chart reviewProcedure: computed tomographyProcedure: computer-aided detection/diagnosis

Interventions

medical chart reviewOTHER
Budesonide ArmPlacebo Arm
computed tomographyPROCEDURE
Budesonide ArmPlacebo Arm
computer-aided detection/diagnosisPROCEDURE
Budesonide ArmPlacebo Arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

Related Publications (1)

  • Veronesi G, Lazzeroni M, Szabo E, Brown PH, DeCensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Grimaldi MC, Spaggiari L, Bonanni B. Long-term effects of inhaled budesonide on screening-detected lung nodules. Ann Oncol. 2015 May;26(5):1025-1030. doi: 10.1093/annonc/mdv064. Epub 2015 Feb 11.

    PMID: 25672894DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsPrecancerous Conditions

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

  • Powel H. Brown, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 29, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

IT(1)