Clinical trial · Observational
Validation of a Multi-gene Test for Lung Cancer Risk
NCT01130285CI-TRIAL-00090784active not recruitingClinicalTrials.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)
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lung Cancer Risk Test | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-Lung Cancer, Heavy Smoker
- description
- Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment.
- interventionNames
- Genetic: Lung Cancer Risk Test
Primary outcomes (1)
- measure
- Accuracy of LCRT to predict incidental lung cancer
- timeFrame
- from time of enrollment
- description
- Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 20 or more pack year smoking history * clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy Exclusion Criteria: * Lung Cancer within 3 months after the date of enrollment
References
Publications (1)
- BACKGROUNDCrawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC. Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository. BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4. PMID 26801409