Clinical trial · Observational
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
NCT01540552CI-TRIAL-00009139completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| computer-aided detection/diagnosis | Procedure | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Budesonide Arm
- description
- Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide.
- interventionNames
- Other: medical chart review
- Procedure: computed tomography
- Procedure: computer-aided detection/diagnosis
- label
- Placebo Arm
- description
- Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo.
- interventionNames
- Other: medical chart review
- Procedure: computed tomography
- Procedure: computer-aided detection/diagnosis
Primary outcomes (1)
- measure
- Natural evolution of lung nodules
- timeFrame
- 5 year review period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- DERIVEDVeronesi 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 25672894