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Correlation of [D10] Phenanthrene Metabolism With Bronchoepitheial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder

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Trial Information

Correlation of [D10] Phenanthrene Metabolism With Bronchoepitheial Dysplasia and Metaplasia in Smokers at High Risk for Lung 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Urinary deuterated phenanthrene tetraol level

Outcome Description:

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.

Outcome Time Frame:

Up to 6 hours

Safety Issue:

No

Principal Investigator

Alex Adjei

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 194611

NCT ID:

NCT01673711

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Lung Cancer
  • Squamous Lung Dysplasia
  • Tobacco Use Disorder
  • Lung Neoplasms
  • Tobacco Use Disorder

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263