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OpenTrials
Active, Not Recruiting

NCT Number: NCT01130285

Validation of a Multi-gene Test for Lung Cancer Risk

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Cancer Risk Test

Genetic

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

Other names: LCRT

Primary outcomes

  1. Accuracy of LCRT to predict incidental lung cancer

    Time frame: from time of enrollment

    Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).

Sponsors and collaborators

Lead sponsor

University of Toledo Health Science Campus

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
May 25, 2010
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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