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

M.D. Anderson Cancer Center

Status

Completed

Conditions

Precancerous Condition

Lung Cancer

Treatments

Other: medical chart review

Procedure: computer-aided detection/diagnosis

Procedure: computed tomography

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01540552

PA11-1128

CDR0000726610 (Other Identifier)

MDA-MDA05-5-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

320 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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