This trial is active, not recruiting.

Condition lung cancer
Treatment lung cancer risk test
Sponsor University of Toledo Health Science Campus
Collaborator National Cancer Institute (NCI)
Start date May 2011
End date August 2018
Trial size 403 participants
Trial identifier NCT01130285, 1RC2CA148572-01, UTHSC - 11


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.
lung cancer risk test LCRT
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.

Primary Outcomes

Accuracy of LCRT to predict incidental lung cancer
time frame: from time of enrollment

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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

Additional Information

Official title Validation of a Multi-gene Test for Lung Cancer Risk
Principal investigator James Willey, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Toledo Health Science Campus.