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OpenTrials
Completed

NCT Number: NCT00598143

Biomarkers of Molecular Risk in Smokers

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: conclusion of study

Secondary outcomes

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

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Vanderbilt University School of Medicine
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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