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Validation of a Multi-gene Test for Lung Cancer Risk

Validation of a Multi-gene Test for Lung Cancer Risk

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01130285
Enrollment
403
Registered
2010-05-25
Start date
2011-05-31
Completion date
2026-09-30
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung Cancer

Brief summary

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.

Detailed description

Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Interventions

GENETICLung Cancer Risk Test

Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Toledo Health Science Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of LCRT to predict incidental lung cancerfrom time of enrollmentTime of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026