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

Tracking Information

First Received Date ^ICMJE

May 8, 2007

Last Updated Date

June 14, 2011

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Metabolic polymorphisms [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00471978 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

DNA Analysis of Blood and Tissue From Patients With Lung Cancer

Official Title ^ICMJE

Molecular and Genetic Analysis of Lung Cancer

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 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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: diagnostic laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

6800

Completion Date

Not Provided

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00471978

Other Study ID Numbers ^ICMJE

CDR0000450128, MGH-1999-P-004935/26, MGH-90-7197

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

David C. Christiani, MD

Massachusetts General Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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