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Assessment of Early Genetic Changes in Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200408
Recruitment Status : Terminated (unable to obtain funding)
First Posted : September 20, 2005
Last Update Posted : April 8, 2015
Information provided by:
Montefiore Medical Center

Brief Summary:
This study will look at the genetic profile of cells taken from the oral cavity of healthy college students who smoke and who do not smoke cigarettes. This will be done using a small brush similar to that used in Pap tests for cervical cancer detection. Our aim is to determine if smoking causes early genetic changes in the DNA of these cells such as have been seen in the cells of cancerous tumors of the head and neck area and nearby healthy tissues. This will be correlated with data from subject questionnaires to assess tobacco use, and other behavior and demographic information.

Condition or disease
Cancer of Head and Neck Smoking

Detailed Description:

Our pilot study using cellular DNA (cDNA) microarrays to examine the buccal mucosa of smokers and non-smokers demonstrated that smokers could be separated from non-smokers based solely on the patterns of gene expression observed. We were able to identify 924 genes whose expression differs significantly between samples from smokers and non-smokers. Several genes were also shown to be either up or down regulated in our earlier research applying microarray analysis to head and neck cancer tumors. Many of these represent genes of possible interest as early molecular markers for head and neck carcinogenesis.

Aberrant methylation is an important event in the transcriptional silencing of candidate tumor suppressor genes in smoking associated malignancies. Furthermore, it is known that methylated CpG islands are the preferred binding site for benzo(a)pyrene diol epoxide and other carcinogens found in tobacco smoke. Binding of these compounds is known to cause DNA adducts and transversion mutations that are often observed in the aerodigestive tumors of smokers. New evidence suggests that specific DNA methylation events are directly linked to tobacco use. The ability to detect such molecular markers during screening of high risk groups would represent a significant advance in cancer screening and early detection. Our group has evaluated specimens to epigenetically profile CpG island hypermethylation in. head and neck squamous cell carcinoma ( HNSCC) tumor samples using a technique known as methylation specific restriction enzyme microarray analysis. This method will be used in this trial to detect alterations in global DNA methylation patterns in subjects who smoke compared to those who don't.

The objectives of this study are:

  1. Test the hypothesis that there are specific genetic alterations, leading to gene expression profile changes, which will be detected in early smokers.
  2. Test the hypothesis that early smokers will demonstrate alterations in global DNA methylation patterns compared to matched controls.
  3. To analyze gene alterations and DNA methylation in college smokers over time through longitudinal follow-up.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Early Genetic Changes in Smokers
Study Start Date : March 2004
Actual Primary Completion Date : January 2005

college students who smoke
non smokers
college students who don't smoke

Primary Outcome Measures :
  1. alteration of gene expression profile [ Time Frame: 2 yrs ]
    comparison of gene expression profiles between smokers and non-smokers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy smokers and non-smokers

Inclusion Criteria:

College freshmen and sophomores

Smokers must be between the ages of 18 and 25

Smokers must have smoked regularly for at least 2 years and be currently smoking

Smokers must intend to stay in the New York area for at least 3 years.

Non-smokers must be non-users of marijuana -

Exclusion Criteria:

Current HIV/AIDS infection

Use of chewing tobacco


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200408

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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Study Chair: Richard V Smith, MD Montefiore Medical Center
Principal Investigator: Thomas Belbin, PhD Albert Einstein College of Medicine
Principal Investigator: Nicholas Schlecht, PhD Albert Einstein College of Medicine
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Responsible Party: Richard V. Smith, MD, MOntefiore Medical Center Identifier: NCT00200408    
Other Study ID Numbers: 04-01-008S
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Montefiore Medical Center:
cancer of head and neck
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site