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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673711
• Other study ID #: 2011NTUC092
• Secondary ID: NCI-2012-01148
• Status: Completed
• Start date: July 2012
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• deuterated phenanthrene tetraol
Given PO
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
Canada	BC Cancer Agency	Vancouver	British Columbia
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary deuterated phenanthrene tetraol level	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.	Up to 6 hours
Primary	PheT:HOPhe ratio	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.	Up to 6 hours
Primary	Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia	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.	Up to 6 hours