NCT07134426

Brief Summary

Some people who used to smoke cigarettes continue to be at higher risk of developing lung cancer, even years after quitting. This study will look to see if a specific chemical, phenanthrene, is broken down in the lungs of former smokers through more harmful pathways than never-smokers. If former smokers break down chemicals that enter their lungs through more harmful pathways this might be putting them at higher risk for developing lung cancer even though they quit smoking. This information may help find better ways to prevent or treat cancer in the future. This study is under an IND, but the drug is not being studied; instead, it is being used as a marker for drug metabolism.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

August 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

August 14, 2025

Last Update Submit

March 2, 2026

Conditions

Keywords

SmokingTobaccoVapingFormer SmokerNon-Smoker

Outcome Measures

Primary Outcomes (2)

  • Urinary Ratio of D10PheT/D9PhOH

    The ratio of D10-phenanthrene tetraol to D9-phenanthrene phenols in the urine will determine how the lung breaks down a class of cancer-causing chemicals called Polycyclic Aromatic Hydrocarbons (PAHs). The higher this ratio the more the lungs break down these chemicals through harmful pathways, which might increase cancer risk. The lower the ratio the more the lung breaks down the chemicals through safer pathways.

    24 hours after vaping phenanthrene

  • TNE

    Total nicotine equivalents will be measured in the urine samples to confirm that study participants are not using tobacco or nicotine products.

    Baseline measure

Study Arms (1)

D10-phenanthrene

OTHER

All study participants (Former Daily Smokers and Non-smokers) will be asked to vape D10-phenanthrene to see how their lungs breakdown a class of cancer-causing chemicals known as polycyclic aromatic hydrocarbons \[PAHs\].

Other: D10-phenanthrene

Interventions

All study participants (Former Daily Smokers and Non-smokers) will be asked to vape D10-phenanthrene to see how their lungs breakdown a class of cancer-causing chemicals known as polycyclic aromatic hydrocarbons \[PAHs\].

D10-phenanthrene

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 21 years of age
  • In good physical \& mental health
  • In stable physical \& mental health
  • Have tried vaping
  • Former daily cigarette smokers who quit 1-20 year ago
  • Non-smokers who have not used tobacco or nicotine products

You may not qualify if:

  • Has any respiratory disease (ex - asthma, COPD, etc...)
  • Has/had high blood pressure
  • Has/had liver disease
  • Has/had cancer
  • Has experience negative effects when vaped previously
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking CessationSmokingVaping

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Stephen Hecht

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All study participants (Former Daily Smokers and Non-smokers) will be asked to vape D10-phenanthrene to see how their lungs breakdown a class of cancer-causing chemicals known as polycyclic aromatic hydrocarbons \[PAHs\].
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 21, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations