NCT00218179

Brief Summary

Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

September 16, 2005

Last Update Submit

January 19, 2017

Conditions

Tobacco Use DisorderLung Cancer

Keywords

Lung CancerCotinineNNALCarcinogensCase-controlSNPs

Outcome Measures

Primary Outcomes (1)

  • Lung cancer

    Cumulative incidence

Study Arms (2)

Cases

Lung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO

Other: Non-intervention

Controls

Subjects without lung cancer among smokers at baseline in the PLCO study

Other: Non-intervention

Interventions

Non-interventionOTHER

Measured total NNAL and PheT as biomarkers of exposure

Also known as: NNAL-glucuronide, phenanthrene tetraol
CasesControls

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Case-control study nested within the Prostate Lung Colorectal and Ovarian Cancer Screening Trial. Subjects consisted of screening arm subjects who were smokers at baseline and who contributed biorepository samples at the first screening visit.

You may qualify if:

  • Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
  • Reported smoking on baseline questionnaire of PLCO
  • Contributed biorepository samples

You may not qualify if:

  • Unstable physical or mental health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

  • Church TR, Haznadar M, Geisser MS, Anderson KE, Caporaso NE, Le C, Abdullah SB, Hecht SS, Oken MM, Van Ness B. Interaction of CYP1B1, cigarette-smoke carcinogen metabolism, and lung cancer risk. Int J Mol Epidemiol Genet. 2010 Aug 5;1(4):295-309.

    PMID: 21532841RESULT

  • Church TR, Anderson KE, Caporaso NE, Geisser MS, Le CT, Zhang Y, Benoit AR, Carmella SG, Hecht SS. A prospectively measured serum biomarker for a tobacco-specific carcinogen and lung cancer in smokers. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):260-6. doi: 10.1158/1055-9965.EPI-08-0718.

    PMID: 19124507RESULT

  • Fang G, Haznadar M, Wang W, Yu H, Steinbach M, Church TR, Oetting WS, Van Ness B, Kumar V. High-order SNP combinations associated with complex diseases: efficient discovery, statistical power and functional interactions. PLoS One. 2012;7(4):e33531. doi: 10.1371/journal.pone.0033531. Epub 2012 Apr 19.

    PMID: 22536319RESULT

MeSH Terms

Conditions

Tobacco Use DisorderLung Neoplasms

Interventions

4-((methylnitrosoamino)-1-(3-pyridyl)but-1-yl)beta-omega-glucosiduronic acidphenanthrene tetraol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Timothy Church, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

US(1)