Clinical trial · Observational
Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer
NCT01673711CI-TRIAL-00041075completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Squamous Lung Dysplasia | — | UNRESOLVED | — |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| deuterated phenanthrene tetraol | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Drug | — | UNRESOLVED |
| pharmacological study | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Basic Science (deuterated phenanthrene tetraol)
- description
- Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
- interventionNames
- Drug: deuterated phenanthrene tetraol
- Drug: pharmacological study
- Drug: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Urinary deuterated phenanthrene tetraol level
- timeFrame
- Up to 6 hours
- 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.
- measure
- PheT:HOPhe ratio
- timeFrame
- Up to 6 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.