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DNA Analysis in Predicting Lung Cancer Risk

This study is currently recruiting participants.
Study NCT00559325.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  DNA Analysis in Predicting Lung Cancer Risk
Official Title  DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Observational
Study Design 
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
Secondary Outcome Measure  Gene-neuro-behavioral interactions for smoking addiction in the control groups
Relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk
Condition  Lung Cancer
Intervention  Procedure: evaluation of cancer risk factors
Procedure: gene expression analysis
Procedure: laboratory biomarker analysis
Procedure: mutation analysis
Procedure: polymorphism analysis
Procedure: proteomic profiling
Procedure: questionnaire administration
MEDLINE PMIDs 17848669,   16896050,   16230422,   12584177,   17301252
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  3000
Start Date  June 1995
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00559325
Organization ID CDR0000566029
Secondary IDs †† NCI-OH98-C-N027
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Principal Investigator:     Elise D. Bowman     NCI - Center for Cancer Research-Medical Oncology    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  November 15, 2007
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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