Biomarkers of Molecular Risk in Smokers

NCT00598143 | Completed

• 1 other identifier: 04-141
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.

  conclusion of study

Secondary Outcomes (1)

• Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.

  conclusion of study

Study Arms (2)

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

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

Interventions

Vignette, questionnaires and Saliva Samples BEHAVIORAL

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 A

Urine Collection, Smoking cessation treatment BEHAVIORAL

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• Arm A
• years or older;
• \>5 packyear history of smoking;
• Ability to understand and sign informed consent.
• Arm B
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator
• Vanderbilt University School of Medicine: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Samples

MeSH Terms

Conditions

Smoking Cessation

Interventions

Surveys and Questionnaires; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jay Boyle, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: February 1, 2005
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)