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

Completed

• Conditions: Squamous Lung Dysplasia; Lung Cancer; Tobacco Use Disorder
• Interventions: Drug: deuterated phenanthrene tetraol; Drug: pharmacological study; Drug: laboratory biomarker analysis

• Registration Number: NCT01673711
• Lead Sponsor: University of Minnesota

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2019-03-31
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic Science (deuterated phenanthrene tetraol)	pharmacological study	Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Basic Science (deuterated phenanthrene tetraol)	deuterated phenanthrene tetraol	Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Basic Science (deuterated phenanthrene tetraol)	laboratory biomarker analysis	Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.

Primary Outcome Measures

Name	Time	Method
Urinary deuterated phenanthrene tetraol level	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	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	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.

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States