NCT01673711

Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the relationship between urinary deuterated (\[D10\]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI). OUTLINE: Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.

Conditions

• Lung Cancer
• Squamous Lung Dysplasia
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	deuterated phenanthrene tetraol	Given PO
DRUG	pharmacological study	Correlative studies
DRUG	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-07-01
• Primary completion: 2019-03-31
• Completion: 2019-09-30
• First posted: 2012-08-28
• Last updated: 2019-10-09

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study