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DNA Analysis in Predicting Lung Cancer Risk

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559325
  Purpose

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.


Condition Intervention
Lung Cancer
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

MedlinePlus related topics:   Cancer    Lung Cancer   

U.S. FDA Resources

Study Type:   Observational
Official Title:   DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Measures:
  • Gene-neuro-behavioral interactions for smoking addiction in the control groups
  • Relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk

Estimated Enrollment:   3000
Study Start Date:   June 1995
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559325

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office     Recruiting
      Bethesda, Maryland, United States, 20892-1182
      Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        

Sponsors and Collaborators

Investigators
Principal Investigator:     Elise D. Bowman     National Cancer Institute (NCI)    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000566029, NCI-OH98-C-N027
First Received:   November 15, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00559325
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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