Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT01673711
Previous Study | Return to List | Next Study

Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01673711
First received: August 2, 2012
Last updated: August 21, 2014
Last verified: January 2014

August 2, 2012
August 21, 2014
July 2012
October 2014   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
Correlation of [D10] Phenanthrene Metabolism With Bronchoepitheial 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. Urine samples are collected for laboratory studies 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
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in the High Risk Lung Cancer (HRLC) Screening Program
  • Eligible for bronchoscopy or have undergone screening bronchoscopy in the past
  • Current smoker of at least 10 cigarettes daily
  • Able to provide written consent indicating an understanding of the investigational nature of the study
  • Willing to take [D10]phenanthrene in water with 20% ethanol

Exclusion Criteria:

  • Previous aerodigestive tract cancer
  • Currently attempting to cut down or quit smoking
  • Major medical co-morbidities, for example, renal dysfunction, heart failure, and diabetes, to be adjudicated by study physicians
  • Pregnant women, women intending to become pregnant, or women who are breastfeeding
  • Former or recovering alcoholics
  • Those needing to take medications such as metronidazole, chlorpromazine, Antabuse or benzodiazepines within 7 days of the deuterated phenanthrene dosing, as they could potentially interact with ethanol; ineligibility based on use of other medications is at the discretion of the study physicians
Both
18 Years and older
No
United States
 
NCT01673711
2011NTUC092, NCI-2012-01148
Yes
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
January 2014

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