NCT01673711

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

6.8 years

First QC Date

August 2, 2012

Last Update Submit

October 8, 2019

Conditions

Lung CancerSquamous Lung DysplasiaTobacco Use Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Basic Science (deuterated phenanthrene tetraol)

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

Drug: deuterated phenanthrene tetraolDrug: pharmacological studyDrug: laboratory biomarker analysis

Interventions

deuterated phenanthrene tetraolDRUG

Given PO

Also known as: [D10] phenanthrene, phenanthrene-D10
Basic Science (deuterated phenanthrene tetraol)
pharmacological studyDRUG

Correlative studies

Also known as: pharmacological studies
Basic Science (deuterated phenanthrene tetraol)
laboratory biomarker analysisDRUG

Correlative studies

Basic Science (deuterated phenanthrene tetraol)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy current and former smokers

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood, buccal swab

MeSH Terms

Conditions

Lung NeoplasmsTobacco Use Disorder

Interventions

phenanthrene

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Stephen S Hecht, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 28, 2012

Study Start

July 1, 2012

Primary Completion

March 31, 2019

Study Completion

September 30, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations

CA(1)US(2)