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Completed

NCT Number: NCT01673711

Deuterated Phenanthrene Tetraol in Smokers Who Are 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.

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Key information

Conditions

Lung Cancer Chemically-Induced Disorders Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Lung Dysplasia Substance-Related Disorders Thoracic Neoplasms Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BC Cancer Agency, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

deuterated phenanthrene tetraol

Drug

Given PO

Other names: [D10] phenanthrene, phenanthrene-D10

pharmacological study

Drug

Correlative studies

Other names: pharmacological studies

laboratory biomarker analysis

Drug

Correlative studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2012
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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