Validation of a Multi-gene Test for Lung Cancer Risk

University of Toledo Health Science Campus

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Genetic: Lung Cancer Risk Test

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01130285

1RC2CA148572-01 (U.S. NIH Grant/Contract)

UTHSC - 11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 403 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

403 participants in 1 patient group

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.

Treatment:

Genetic: Lung Cancer Risk Test