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
  Purpose
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.

Condition Intervention
Lung Cancer
Squamous Lung Dysplasia
Tobacco Use Disorder
Radiation: deuterated phenanthrene tetraol
Other: pharmacological study
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673711

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori Berstrom, RN    507-538-1887    bergstrom.lori@mayo.edu   
Principal Investigator: David E Midthun, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    AKSRPCI@roswellpark.org   
Principal Investigator: Alex A. Adjei         
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Lung Health Study    1-888-675-8001 ext 8088      
Principal Investigator: Stephen Lam, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen S Hecht, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01673711     History of Changes
Other Study ID Numbers: 2011NTUC092  NCI-2012-01148 
Study First Received: August 2, 2012
Last Updated: May 13, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2016