Trial record 1 of 1 for:    NCT01673711
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Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01673711
First received: August 2, 2012
Last updated: May 13, 2016
Last verified: May 2016

August 2, 2012
May 13, 2016
July 2012
December 2017   (final data collection date for primary outcome measure)
  • Urinary deuterated phenanthrene tetraol level [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01673711 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Lung Cancer
  • Squamous Lung Dysplasia
  • Tobacco Use Disorder
  • Radiation: deuterated phenanthrene tetraol
    Given PO
    Other Names:
    • [D10] phenanthrene
    • phenanthrene-D10
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Interventions:
  • Radiation: deuterated phenanthrene tetraol
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
December 2017
December 2017   (final data collection date for primary outcome measure)
  • 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, planning on becoming 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
Both
18 Years and older   (Adult, Senior)
Yes
United States,   Canada
 
NCT01673711
2011NTUC092, NCI-2012-01148
Yes
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Principal Investigator: Stephen S Hecht, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP