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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.
Verified November 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673711
First Posted: August 28, 2012
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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 Other: deuterated phenanthrene tetraol Other: pharmacological study Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
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 ]
    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 ]
    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 ]
    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.


Biospecimen Retention:   Samples With DNA
Urine, blood, buccal swab

Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
Other: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy current and former smokers
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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Completed
Buffalo, New York, United States, 14263
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 2, 2012
First Posted: August 28, 2012
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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