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Biomarkers of Molecular Risk in Smokers


N/A
18 Years
N/A
Open (Enrolling)
Both
Smoking Cessation

Thank you

Trial Information

Biomarkers of Molecular Risk in Smokers


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Jay Boyle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-141

NCT ID:

NCT00598143

Start Date:

February 2005

Completion Date:

February 2014

Related Keywords:

  • Smoking Cessation
  • Smoking

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021