Clinical trial NCT01673711: Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
Official title: Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Squamous Lung Dysplasia
Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy current and former smokers

Brief summary: 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.

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 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

Primary outcomes:
measure: Urinary deuterated phenanthrene tetraol level
timeFrame: Up to 6 hours
measure: PheT:HOPhe ratio
timeFrame: Up to 6 hours
measure: Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia
timeFrame: Up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: University of Minnesota
name: Stephen S Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References: