Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
|Lung Cancer Squamous Lung Dysplasia Tobacco Use Disorder||Radiation: deuterated phenanthrene tetraol Other: pharmacological study Other: laboratory biomarker analysis|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer|
- Urinary deuterated phenanthrene tetraol level [ Time Frame: Up to 6 hours ]A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
- PheT:HOPhe ratio [ Time Frame: Up to 6 hours ]A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
- Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia [ Time Frame: Up to 6 hours ]A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Radiation: deuterated phenanthrene tetraol
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
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).
Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673711
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Lori Berstrom, RN 507-538-1887 firstname.lastname@example.org|
|Principal Investigator: David E Midthun, MD|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 AKSRPCI@roswellpark.org|
|Principal Investigator: Alex A. Adjei|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Lung Health Study 1-888-675-8001 ext 8088|
|Principal Investigator: Stephen Lam, MD|
|Principal Investigator:||Stephen S Hecht, PhD||University of Minnesota - Clinical and Translational Science Institute|