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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Lung Cancer; Squamous Lung Dysplasia
• Intervention / Treatment: Drug: deuterated phenanthrene tetraol; Drug: pharmacological study; Drug: laboratory biomarker analysis

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy current and former smokers

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Basic Science (deuterated phenanthrene tetraol); Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.	Drug: deuterated phenanthrene tetraol; Given PO; Other Names: [D10] phenanthrene; phenanthrene-D10; Drug: pharmacological study; Correlative studies; Other Names: pharmacological studies; Drug: laboratory biomarker analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 6 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephen S Hecht, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2012
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Tobacco Use Disorder
• Other Study ID Numbers: 2011NTUC092; NCI-2012-01148 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No