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DNA Analysis in Predicting Lung Cancer Risk
This study is currently recruiting participants.
Study NCT00559325   Information provided by National Cancer Institute (NCI)
First Received: November 15, 2007   Last Updated: June 9, 2009   History of Changes

November 15, 2007
June 9, 2009
June 1995
April 2010   (final data collection date for primary outcome measure)
  • Prediction of lung cancer risk based on mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes
  • Development of phenotypic or predictive markers of lung cancer, including mutagen sensitivity, DNA damage-induced cell cycle checkpoints, and serum proteomics
Same as current
Complete list of historical versions of study NCT00559325 on ClinicalTrials.gov Archive Site
  • Gene-neuro-behavioral interactions for smoking addiction in the control groups
  • Relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk
Same as current
 
DNA Analysis in Predicting Lung Cancer Risk
DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer

RATIONALE: Studying samples of blood, urine, and tissue from patients with lung cancer and from other participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict risk for developing lung cancer.

PURPOSE: This clinical trial is studying the DNA in blood, urine, and tissue samples from patients with lung cancer and from other participants.

OBJECTIVES:

Primary

  • To determine if mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes is predictive of lung cancer risk.
  • To investigate and develop phenotypic or predictive markers of lung cancer, including mutagen sensitivity, DNA damage-induced cell cycle checkpoints, and serum proteomics.

Secondary

  • To demonstrate gene-neuro-behavioral interactions for smoking addiction in the control groups.
  • Determine the relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk.

OUTLINE: Cases and controls undergo a structured, in-person interview assessing prior medical history and cancer history, tobacco use, alcohol use, current medications, occupational history, family medical history, menstrual history and estrogen use, recent nutritional supplement use, caffeine intake, and socioeconomic status.

Cases and controls also undergo blood and urine sample collection for DNA analysis. The phenotypic markers studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in vitro to radiation, bleomycin, and benzo(a)pyrene-diol-epoxide and measuring induction of chromosomal aberrations, p53 induction, and apoptosis. DNA from cases and controls are also used for genetic polymorphism analysis of carcinogen metabolism, and those related to the dopaminergic system and nicotinic receptors. Previously collected tumor tissue samples from cases are evaluated for estrogen and progesterone receptors.

 
Observational
 
Lung Cancer
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Procedure: evaluation of cancer risk factors
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3000
 
April 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Histologically confirmed non-small cell lung cancer (case)

      • Diagnosed within the past 6 months
    • Frequency matched to cases according to age (5-year intervals), gender, race, smoking status, and hospital (hospital control)
    • Frequency matched to cases according to age (5-year intervals), gender, and race (population-based control)
  • Resides in Baltimore City or contiguous metropolitan counties (i.e., Prince George's County or Anne Arundel County)

PATIENT CHARACTERISTICS:

  • Has a residential working phone within the home
  • Speaks English well enough to be interviewed
  • Born in the United States
  • Physically and mentally capable of performing the interview (i.e., must be able to hear the interviewer, mentally comprehend the interviewers questions, and verbally respond)
  • Has never been interviewed as a control for this study
  • Does not currently reside in an institution such as a prison, nursing home, or shelter
  • No severe illness requiring an intensive care unit (ICU) (case or hospital control)

    • May be eligible for study participation after discharge from ICU
  • No known diagnosis of HIV or hepatitis B or C (case or hospital control)
  • No history of cancer other than nonmelanoma skin cancer or carcinoma in situ of the cervix (hospital control or population control)

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years and older
Yes
 
United States
 
NCT00559325
 
CDR0000566029, NCI-OH98-C-N027
National Cancer Institute (NCI)
 
Principal Investigator: Elise D. Bowman National Cancer Institute (NCI)
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP