Biomarkers of Molecular Risk in Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Vanderbilt University School of Medicine
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00598143
First received: January 9, 2008
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Doctors at MSKCC are doing this research study to see if smokers are interested in the idea that genes might be markers of cancer risk, and to see if smokers would want to learn this information about their risk if it were available.

Different versions of the gene called UGT1A7 are found in different people. Certain versions of this gene can increase the risk of cancer in people. In this study, doctors will determine the different types of UGT1A7 in smokers and find out whether smokers show good interest and understanding. The information from this study will be used in future studies to identify smokers at increased risk for cancer, and to help smokers quit.


Condition Intervention
Smoking Cessation
Behavioral: Vignette, questionnaires and Saliva Samples
Behavioral: Urine Collection, Smoking cessation treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Molecular Risk in Smokers

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva Samples


Estimated Enrollment: 40
Study Start Date: February 2005
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Ten healthy smokers will provide a saliva sample used to genotype UGT1A7 and complete a questionnaire to assess understanding of and willingness to participate in molecular risk assessments.
Behavioral: Vignette, questionnaires and Saliva Samples
The short vignette discusses the health implications of potential molecular markers of cancer risk assessment. The questionnaire asks several multiple-choice questions to assess the participant's interest in and understanding of molecular risk assessment. Patients are instructed to swish with 10cc of Scope mouthwash and to expectorate into a sterile 50cc conical tube.
Group B
Thirty smokers will receive standard smoking cessation therapy and provide urine specimens for PGE-M analysis at approximate 3-monthly intervals over one year. Self-reported smoking status and expired-air carbon monoxide (CO) will also be recorded at 3-monthly clinic visits.
Behavioral: Urine Collection, Smoking cessation treatment
Single void urine specimens (approximately 50 ml) will be collected in pre-labeled specimen containers on a 3-monthly (±1 month) basis for 12 months. Standard evidence-based therapy for smoking cessation, including behavioral therapy and pharmacological therapy, is provided.

Detailed Description:

This study consists of two arms; both of which are observational studies of molecular assessments of risk for tobacco related cancer. Arm A of the protocol is a pilot crosssectional study that evaluates the feasibility of obtaining and testing a genetic marker of cancer susceptibility (UGT1A7 polymorphisms) in smokers. It also explores smokers' interest in and comprehension of genetic risk assessments as possible tools for increasing motivation for smoking cessation. The second arm of this protocol, Arm B, is an observational prospective evaluation of a putative noninvasive biomarker of tobacco smoke exposure - urinary prostaglandin E-metabolite (PGE-M) - in smokers motivated to reduce and/or cease smoking.

  Eligibility

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

MSKCC clinics

Criteria

Inclusion Criteria:

  • Arm A
  • 18 years or older;
  • >5 packyear history of smoking;
  • Ability to understand and sign informed consent.
  • Arm B
  • 18 years or older;
  • >10 packyear history of smoking;
  • Intention to taper and/or quit smoking within 6 months
  • Ability to understand and sign informed consent.

Exclusion Criteria:

  • Arm A
  • Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin cancer).
  • Arm B
  • Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin cancer).
  • Use of any COX-2 inhibitor, steroid, or non-steroidal anti-inflammatory medication (excluding cardioprotective aspirin > 81mg/d) within one week of urine collection
  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: NCT00598143

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Vanderbilt University School of Medicine
Investigators
Principal Investigator: Jay Boyle, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00598143     History of Changes
Other Study ID Numbers: 04-141
Study First Received: January 9, 2008
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014