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Clinical Trials/NCT00471978
NCT00471978
Recruiting
Not Applicable

Molecular and Genetic Analysis of Lung Cancer

Massachusetts General Hospital2 sites in 1 country6,800 target enrollmentSeptember 2005
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Massachusetts General Hospital
Enrollment
6800
Locations
2
Primary Endpoint
Metabolic polymorphisms
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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 began as a case-control study, but is currently case only. 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 early phases of this study. Total enrollment to reach 15,000.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
September 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Christopher Christiani

Elkan Blout Professor of Enviromental Genetics, Professor of Medicine

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Metabolic polymorphisms

Time Frame: 10 years

to compare differences among lung cancer patients

Study Sites (2)

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