Clinical trial NCT01540552: Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
Official title: Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Precancerous Condition
Keywords: lung cancer
precancerous condition
lung nodules
CT Scan
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-29
Enrollment: 320
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Natural evolution of lung nodules
timeFrame: 5 year review period
Secondary outcomes:
measure: Lung cancer detection rate
timeFrame: 5 year review period
measure: Appearance of new nodules
timeFrame: 5 year review period
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Powel H. Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.