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Assessment of Early Genetic Changes in Smokers

This study has been withdrawn prior to enrollment.
(unable to obtain funding)
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00200408
First received: September 13, 2005
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

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
Cancer of Head and Neck
Smoking

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Early Genetic Changes in Smokers

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Estimated Enrollment: 140
Study Start Date: March 2004
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Our pilot study using 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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy smokers and non-smokers

Criteria

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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200408

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Study Chair: Richard V Smith, MD Montefiore Medical Center
Principal Investigator: Thomas Belbin, PhD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Nicholas Schlecht, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Richard V. Smith, MD, MOntefiore Medical Center
ClinicalTrials.gov Identifier: NCT00200408     History of Changes
Other Study ID Numbers: 04-01-008S
Study First Received: September 13, 2005
Last Updated: November 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Montefiore Medical Center:
cancer of head and neck
smoking

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014