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NCT01038492 · ClinicalTrials.gov registry record · NA

p16 Methylation for Smoking Cessation

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
35
Enrollment target

NCT01038492: Completed NA study, sponsored by Duke University.

NCT01038492 is a NA study that has completed, run by Duke University. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01038492, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target

Study Summary

Smoking cessation is often difficult for smokers to achieve for a variety of reasons including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking cessation, and failure to perceive the risks associated with smoking. We argue that the most effective biomarkers to affect perceptions of harm, especially for lung cancer, are those that signal progression towards disease development Proposed is a pilot study of educating smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal of this pilot study is to assess the interest in study participation from the VA smoking population, as well as to determine the fraction of subjects who will complete the study to power a future larger trial. Interested patients will receive a 15 minute educational presentation on the function of p16 and its role in development of lung cancer. They will then be assessed for airway obstruction by hand-held spirometry followed by review of a questionnaire assessing their understanding of the presented information, their concern for developing lung cancer, and their desire to quit smoking. All patients will be offered smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum cups to take home and return with morning sputum samples by mail. Samples will be assessed for evidence of p16 methylation and patients will be informed of the results. Follow-up phone interviews will be performed at 2 to 4 weeks after patients have received their results by mail to assess their understanding of the results, and their desire to stop smoking. A final phone interview will occur approximately 3 months after the sputum testing to assess attempts to stop smoking as well as the patients continued understanding of their test results. For purposes of this pilot, we are interested primarily in the descriptive statistics (e.g., frequencies) associated with the outcome of each objective (e.g., how many expressed interest, how

Interventions

  • BEHAVIORAL p16 Methylation and Lung Cancer Education

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2009-04
Est. Completion 2010-06
Phase NA
Duke University

1,725 total trials

What the finished NCT01038492 record still lists

NCT01038492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which p16 Methylation and Lung Cancer Education is the first listed.

NCT01038492 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01038492 about?

NCT01038492 is a clinical study titled "p16 Methylation for Smoking Cessation". Smoking cessation is often difficult for smokers to achieve for a variety of reasons including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking cessation, and failure to perceive the risks associated with smoking. We argue that the most effective biomarkers to affect...

What is the current status of trial NCT01038492?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2009-04. Estimated completion is 2010-06.

What interventions are being tested in trial NCT01038492?

The interventions under investigation include: p16 Methylation and Lung Cancer Education (BEHAVIORAL).

Who is sponsoring clinical trial NCT01038492?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01038492's enrollment target sits among peer trials

35 1564th of 2000 higher than 431 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01038492, the US trial registry maintained by the National Library of Medicine. NCT01038492 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.