Clinical Trials

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Title S0424 - Non-Small Cell Lung Cancer in Smoking/Non-Smoking Men and Women
Description The primary objectives of this study are: 1) assess lung tissue from cancer patients for specific tobacco smoke carcinogens and to determine whether these factors differ by gender and smoking status, adjusting for potential exposures and influential factors, including family smoking status, medication use, hormonal and reproductive factors, 2) measure the levels of (PAH)-DNA adducts in lymphocytes and lung tissue, examine correlations between the two tissue sources and to test the hypothesis that DNA damage levels in tissue as well as in lymphocytes are higher in females than males for the same level of smoking, 3) determine polumorphisms in several genes involved in the metabolism of the specific carcinogens investigated and in steroidgenesis and metabolism, 4) summarize patient self-report questionnaire data on active and passive smoking, other carcinogenic exposures, smoking preference, economic and educational status, family smoking status, reproductive factors, weight loss, and medication use by categories of male versus female and never-smoker versus ever-smoker, and 5) establish a repository of blood and archived tissue samples for future laboratory analysis.
IRB Number SC-06-026
Study/Treatment Lung Cancer
Inclusion/Notes "Inclusion:
- Patients must have newly-diagnosed, primary, histologically confirmed Stage I, II, IIIA or IIIB non-small cell lung cancer.
- Patients must not have malignant pleural effusion.
- Patients must not have received prior systemic chemotherapy or radiation therapy for lung cancer.
- Patients must not have pericardial effusions.
- Patients will be allowed to register concurrently in therapeutic trials, but are not required to be on a therapeutic study.
- Patients must have tumor blocks/slides available and must be willing to provide tissue and blood as outlined in the protocol.
- Patients must be able and willing to complete the Lung Cancer Epidemiology Questionnaire per protocol. Patients must be able to read and understand English in order to participate in this study.
- Patients must be identified and registered into the study within 120 days of diagnosis. Final stage designatation must be determined within 42 days prior to registration.
- Patients must be willing to provide prior smoking history.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines."
Contact Name Nancy N. and J.C. Lewis Cancer & Research Pavilion
Phone (912) 819-5704

St. Joseph's Hospital Campus: 11705 Mercy Blvd., Savannah, GA 31419, (p) 912-819-4100

 

Candler Hospital Campus: 5353 Reynolds St., Savannah, GA 31405, (p) 912-819-6000