Clinical Trials

Biomarkers of Molecular Risk in Smokers

Protocol
04-141
Full Title
Biomarkers of Molecular Risk in Smokers
Purpose

Smoking causes cancer and other diseases. People who are trying to quit smoking might be able to quit more easily by learning about their own risk of developing tobacco-related diseases such as head and neck cancer. Researchers at Memorial Sloan-Kettering are conducting this study to see if people can understand that genes and the amounts of certain chemicals in the body might be markers of disease risk, and to see if patients would want to learn this information about their risk if it were available.

Different versions of a gene called UGT1A7 are found in different people. Certain versions of this gene can increase the risk of cancer. In an earlier study, researchers at Memorial Sloan-Kettering showed that PGE-M, a chemical in the urine that reflects the amount of inflammation in the body, is higher in ever-smokers (current and former smokers) compared to never-smokers.

In this two-armed study, investigators want to explore participants¿ interest in and understanding of genetic risk assessments as possible tools for increasing motivation for smoking cessation, and to evaluate whether urinary PGE-M levels decrease as a smoker tapers or quits smoking during the course of 12 months. Additional research studies could be performed in the future to use this information to help smokers quit.

Investigator
Jay O. Boyle, MD -- Director, Fellowship Training Program in Head and Neck Surgery
Jay O. Boyle - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants should be smokers with more than a 5- or 10-pack-year history of smoking who intend to quit within 6 months of entering the study. (The number of pack-years is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.)
  • Participants may not have any diagnosis of any cancer (excluding non-melanoma skin cancer) in the previous year.
  • Participants may not use COX-2 inhibitors, steroids, or any non-steroidal anti-inflammatory agent (excluding 81 mg or less of cardioprotective aspirin) within 1 week of urine collection. Participants must be age 18 or older.

For more information and to see if you are eligible for this study, please contact our Research Study Assistant at 646-227-2224.

Locations
ClinicalTrials.gov