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DNA Analysis of Blood and Tissue From Patients With Lung Cancer

This study is currently recruiting participants.
Verified August 2017 by David Christopher Christiani, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471978
First Posted: May 10, 2007
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Christopher Christiani, Massachusetts General Hospital
  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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Molecular and Genetic Analysis of Lung Cancer

Resource links provided by NLM:


Further study details as provided by David Christopher Christiani, Massachusetts General Hospital:

Primary Outcome Measures:
  • Metabolic polymorphisms [ Time Frame: 10 years ]
    to compare differences among lung cancer patients


Biospecimen Retention:   Samples With DNA
blood or tissue samples may be collected

Estimated Enrollment: 6800
Study Start Date: September 2005
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: June 2022 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung cancer and health controls
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

EXCLUSIONS:

Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471978


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

Responsible Party: David Christopher Christiani, Elkan Blout Professor of Enviromental Genetics, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00471978     History of Changes
Other Study ID Numbers: CDR0000450128
MGH-1999-P-004935/26 ( Other Identifier: Partners Institutional Review Board )
First Submitted: May 8, 2007
First Posted: May 10, 2007
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Christopher Christiani, Massachusetts General Hospital:
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