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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Squamous Lung Dysplasia Tobacco Use Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Basic Science (deuterated phenanthrene tetraol)

Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.

deuterated phenanthrene tetraol

Intervention Type DRUG

Given PO

pharmacological study

Intervention Type DRUG

Correlative studies

laboratory biomarker analysis

Intervention Type DRUG

Correlative studies

Interventions

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deuterated phenanthrene tetraol

Given PO

Intervention Type DRUG

pharmacological study

Correlative studies

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type DRUG

Other Intervention Names

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[D10] phenanthrene phenanthrene-D10 pharmacological studies

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes