Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01673711|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2012
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment|
|Lung Cancer Squamous Lung Dysplasia Tobacco Use Disorder||Drug: deuterated phenanthrene tetraol Drug: pharmacological study Drug: 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.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Drug: deuterated phenanthrene tetraol
Drug: pharmacological study
Other Name: pharmacological studies
Drug: laboratory biomarker analysis
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673711
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Stephen S Hecht, PhD||University of Minnesota - Clinical and Translational Science Institute|