DNA Analysis of Blood and Tissue from Patients with Lung Cancer
NCT ID: NCT00471978
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
OBSERVATIONAL
2005-09-30
2026-09-30
Brief Summary
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PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.
Detailed Description
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* 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.
Conditions
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Eligibility Criteria
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Exclusion Criteria
18 Years
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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David Christopher Christiani
Elkan Blout Professor of Enviromental Genetics, Professor of Medicine
Principal Investigators
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David C. Christiani, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Harvard School of Public Health
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Clinical Trials Office - Massachusetts General Hospital
Role: primary
David C. Christiani, MD
Role: primary
Other Identifiers
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MGH-1999-P-004935/26
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000450128
Identifier Type: -
Identifier Source: org_study_id