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DNA Analysis of Blood and Tissue From Patients With Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00471978
First received: May 8, 2007
Last updated: June 14, 2011
Last verified: June 2009
History of Changes
  Purpose

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.


Condition Intervention
Lung Cancer
 Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
Official Title: Molecular and Genetic Analysis of Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Metabolic polymorphisms [ Designated as safety issue: No ]

Estimated Enrollment: 6800
Study Start Date: September 2005
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
  • Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
  • Assess the roles of gender and age in the genetic susceptibility of lung cancer.
  • Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
  • Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
  • Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.

OUTLINE: This is a case-control study.

Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.

Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.

PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patient:

    • Newly diagnosed lung cancer

      • Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center

  • Control:

    • Nonblood-related friend or spouse of the patient

      • No specific matching characteristics
    • Friend or spouse of other hospital patients

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471978

Locations
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: David C. Christiani, MD     617-726-9274        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: David C. Christiani, MD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471978     History of Changes
Other Study ID Numbers: CDR0000450128, MGH-1999-P-004935/26, MGH-90-7197
Study First Received: May 8, 2007
Last Updated: June 14, 2011
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013