Biomarkers of Molecular Risk in Smokers

Smoking Cessation Clinical Trial

Official title:

Biomarkers of Molecular Risk in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598143
• Other study ID #: 04-141
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: May 27, 2015
• Start date: February 2005
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Vanderbilt University School of Medicine, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.		conclusion of study	No
Secondary	Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.		conclusion of study	No

External Links

•   Memorial Sloan Kettering Cancer Center