Validation of a Multi-gene Test for Lung Cancer Risk

Lung Cancer Clinical Trial

Official title:

Validation of a Multi-gene Test for Lung Cancer Risk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01130285
• Other study ID #: UTHSC - 11
• Secondary ID: 1RC2CA148572-01
• Status: Active, not recruiting
• Start date: May 2011
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: University of Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 403
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• Lung Cancer Risk Test
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Henry Ford	Detroit	Michigan
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Tennessee Valley Veterans Admin.	Nashville	Tennessee
United States	Vanderbilt	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Mercy St. Vincent Medical Center	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Crawford 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of LCRT to predict incidental lung cancer	Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).	from time of enrollment