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Trial Title:
DNA Analysis of Blood and Tissue From Patients With Lung Cancer
NCT ID:
NCT00471978
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
non-small cell lung cancer
small cell lung cancer
pulmonary carcinoid tumor
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
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 this
study.
Criteria for eligibility:
Study pop:
Patients with lung cancer
Sampling method:
Non-Probability Sample
Criteria:
DISEASE CHARACTERISTICS:
- Patient:
- Newly diagnosed primary lung cancer
- Patient at Massachusetts General Hospital (MGH) or Boston Medical Center
Cancer Center
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
EXCLUSIONS:
Vulnerable populations are excluded. Patients with metastasis from another site to lung
or mesothelioma are excluded.
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Massachusetts General Hospital
Phone:
877-726-5130
Facility:
Name:
Harvard School of Public Health
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
David C. Christiani, MD
Phone:
617-726-9274
Start date:
September 2005
Completion date:
September 2023
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00471978
