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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450281 |
RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers 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 doctors learn more about risk factors for lung cancer and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
Condition | Intervention |
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Lung Cancer |
Procedure: chromogenic in situ hybridization Procedure: fluorescent antibody technique Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: matrix-assisted laser desorption/ionization time of flight mass spectrometry Procedure: mutation analysis Procedure: polymerase chain reaction Procedure: polymorphism analysis Procedure: study of high risk factors Procedure: study of socioeconomic and demographic variables |
Study Type: | Observational |
Official Title: | Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men |
Estimated Enrollment: | 720 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a case-series, multicenter study. Patients are stratified according to gender and smoking status (never smoker [< 100 cigarettes smoked during lifetime] vs ever smoker [≥ 100 cigarettes smoked during lifetime] [closed to accrual as of 7/15/07]).
Patients complete the Lung Cancer Epidemiology Questionnaire for detailed assessment of the following:
Patients are followed annually for up to 5 years.
PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study (female and male smoker strata closed to accrual as of 7/15/07).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
No malignant pleural effusion; if pleural fluid is present, 1 of the following criteria must be met:
Prior smoking history meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No other prior malignancy except for 1 of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Christine B. Ambrosone, PhD | Roswell Park Cancer Institute |
Investigator: | Regina M. Santella, PhD | Herbert Irving Comprehensive Cancer Center |
Investigator: | Kathy S. Albain, MD | Loyola University |
Investigator: | Paul H. Gumerlock, PhD | University of California, Davis |
Study ID Numbers: | CDR0000446084, SWOG-S0424 |
Study First Received: | March 20, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00450281 |
Health Authority: | Unspecified |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIB non-small cell lung cancer stage IIIA non-small cell lung cancer |
Thoracic Neoplasms Smoking Antibodies Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Immunoglobulins Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |