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NCT04228952 · ClinicalTrials.gov registry record

Metabolism of NNK in Japanese Americans

A clinical trial, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
16
Enrollment target

NCT04228952: Completed study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT04228952 is a clinical trial that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04228952 has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
16 participants
Enrollment target

Study Summary

The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups. In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days. This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using \[pyridine- D4\]-NNK containing cigarettes.

Primary Outcome

Difference in means of the ratio of D4-hydroxy acid to D4- NNAL (an estimate if NNK alpha hydroxylation) for the two groups (null versus average CYP2A6 activity)

Interventions

  • COMBINATION_PRODUCT Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2020-09-01
Est. Completion 2025-04-14

What the finished NCT04228952 record still lists

NCT04228952 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK is the first listed.

NCT04228952 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04228952 about?

NCT04228952 is a clinical study titled "Metabolism of NNK in Japanese Americans". The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups. In this 10 day cl...

What is the current status of trial NCT04228952?

This trial is currently completed. The enrollment target is 16 participants. The study started on 2020-09-01. Estimated completion is 2025-04-14.

What interventions are being tested in trial NCT04228952?

The interventions under investigation include: Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04228952?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04228952, the US trial registry maintained by the National Library of Medicine. NCT04228952 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.