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

University of Minnesota350 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Lung Cancer Squamous Lung Dysplasia Tobacco Use Disorder

Interventions

deuterated phenanthrene tetraolDRUG

Given PO

pharmacological studyDRUG

Correlative studies

laboratory biomarker analysisDRUG

Correlative studies

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Current or former smoker * 18 years of age or older * Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy (white light and/or autofluorescence) conducted less than or equal to 10 years prior to registration * Not pregnant or breastfeeding * Able to provide written informed consent indicating an understanding of the nature of the study * Willing to comply with study requirements, including taking \[D10\]phenanthrene in water with 20% ethanol * No previous history of aerodigestive cancer * Not currently undergoing treatment for any cancers. Exception: basal cell or squamous cell skin cancer * Not currently taking any other investigational agents * No history of allergic reaction to \[D10\]phenanthrene or similar compounds * No major medical comorbidities, for example, renal dysfunction, heart function, and diabetes, to be adjudicated by study physicians * Not a former or recovering alcoholic * No use of metronidazole or antabuse less than or equal to 7 days prior to \[D10\]phenanthrene dosing, as they could potentially interact with ethanol

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

BC Cancer Agency

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Urinary deuterated phenanthrene tetraol level

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.

Time frame: Up to 6 hours

PheT:HOPhe ratio

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.

Time frame: Up to 6 hours

Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia

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.

Time frame: Up to 6 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.