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Testing the Feasibility of Using an Epigenetic Marker, p16, to Promote Smoking Cessation

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Tobacco Use Disorder, Smoking Cessation, Lung Cancer

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Trial Information

Testing the Feasibility of Using an Epigenetic Marker, p16, to Promote Smoking Cessation

In the United States during 2007, ~ 213,380 people were expected to be diagnosed with lung
cancer, and ~ 160,390 expected to die of the disease. Among those diagnosed with lung
cancer, 79% to 90% are cigarette smokers. Overall, ~21% of adults in the U.S. smoke. The
most important and cost-effective strategy for the prevention of lung cancer mortality is
smoking avoidance and 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 perceptions of harm,
especially for lung cancer, are those that signal progression towards disease development.
Prior to the development of lung cancer, there are genetic alterations in the bronchial
epithelium. One such alteration is the methylation of the promoter region of Rb-p16 (p16)
important in regulation of the G1-S transition of the cell cycle. Prior studies have shown
that presence of the promoter methylation of p16 results in a 2-fold increase in risk of
developing lung cancer in smokers with evidence of airway obstruction.

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. Patients will be compensated a total of
$40.00 for completing the study. 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 many returned the sputum samples).

Inclusion Criteria:

- current smoker

- >30 pack year history

- FEV1/FVC<70%

- patients in outpatient pulmonary clinics at Durham VAMC and general medicine
outpatient clinics at Durham VA Hillandale Clinic

Exclusion Criteria:

- diagnosis of head, neck, or lung cancer

- diagnosis of psychosis or severe cognitive impairment

- refusal to sign informed consent

- severe speech or hearing impairment

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine patient interest in finding out whether, through the testing of p16 methylation in their sputum, whether they are at increased or average risk for developing cancer

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Scott Shofer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Durham VA Medical Center/Duke University Medical Center


United States: Department of Veterans Affairs

Study ID:




Start Date:

April 2009

Completion Date:

June 2010

Related Keywords:

  • Tobacco Use Disorder
  • Smoking Cessation
  • Lung Cancer
  • Lung Neoplasms
  • Smoking
  • Tobacco Use Disorder



Durham VA Medical Center Durham, North Carolina  27705