Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450281
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2007-03-20
Brief Title:
S0424 - Carcinogens in Lung Tissue From Smokers Closed to Entry as of 71507 and Non-Smokers With Newly Diagnosed Stage I Stage II or Stage III Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying samples of blood and tissue from smokers closed to entry as of 71507 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 71507 and non-smokers with newly diagnosed stage I stage II or stage III non-small cell lung cancer
PURPOSE This clinical trial is studying carcinogens in lung tissue from smokers closed to entry as of 71507 and non-smokers with newly diagnosed stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Assess lung tissue from patients with stage I stage II stage IIIA or stage IIIB non-small cell lung cancer for specific tobacco smoke carcinogens including polycyclic aromatic hydrocarbons PAH and DNA adducts alterations in specific genes including p53 and K-ras and expression of HER2 and estrogen receptors α and β
Determine whether tobacco smoke carcinogens differ by gender and smoking status adjusting for potential exposures and influential factors including family smoking status medication use and hormonal and reproductive factors
Measure the levels of PAH-DNA adducts in lymphocytes and lung tissue and examine correlations between the two tissue sources
Determine whether DNA damage levels in tissue as well as in lymphocytes are higher in females than in males for the same level of smoking
Determine polymorphisms in several genes involved in the metabolism of the specific carcinogens investigated and in steroidogenesis and metabolism
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
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 71507
Patients complete the Lung Cancer Epidemiology Questionnaire for detailed assessment of the following
Exposure to active and passive smoke
Occupational exposures
Reproductive and hormonal risk factors
Weight loss
Economic and educational status
Family smoking status
Medication use
Other variables relevant for the analysis eg HER2 estrogen receptor status Peripheral blood samples are collected for research studies Previously collected tissue samples are also studied in the laboratory Samples are examined for DNA adduct levels Estrogen receptor α and β are assessed by immunohistochemistry IHC HER2 expression and amplification are measured by chromogenic in situ hybridization IHC and DNA-polymerase chain reaction PCR-single-stranded conformational polymorphism assay are used to analyze p53 mutations RAS mutations are analyzed with restriction fragment length polymorphism-PCR assay Polycyclic aromatic hydrocarbons and 4-aminobiphenyl-DNA damage are assessed by IHC and immunofluorescence Matrix-assisted laser desorptionionization time of flight mass spectrometry is used to genotype polymorphisms including CYP1A1 CYP1B1 GSTM1 GSTP1 MPO NAT-1 NAT-2 CYP19 CYP17 SULT1A1
Patients are followed annually for up to 5 years
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study female and male smoker strata closed to accrual as of 71507
Assess lung tissue from patients with stage I stage II stage IIIA or stage IIIB non-small cell lung cancer for specific tobacco smoke carcinogens including polycyclic aromatic hydrocarbons PAH and DNA adducts alterations in specific genes including p53 and K-ras and expression of HER2 and estrogen receptors α and β
Determine whether tobacco smoke carcinogens differ by gender and smoking status adjusting for potential exposures and influential factors including family smoking status medication use and hormonal and reproductive factors
Measure the levels of PAH-DNA adducts in lymphocytes and lung tissue and examine correlations between the two tissue sources
Determine whether DNA damage levels in tissue as well as in lymphocytes are higher in females than in males for the same level of smoking
Determine polymorphisms in several genes involved in the metabolism of the specific carcinogens investigated and in steroidogenesis and metabolism
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
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 71507
Patients complete the Lung Cancer Epidemiology Questionnaire for detailed assessment of the following
Exposure to active and passive smoke
Occupational exposures
Reproductive and hormonal risk factors
Weight loss
Economic and educational status
Family smoking status
Medication use
Other variables relevant for the analysis eg HER2 estrogen receptor status Peripheral blood samples are collected for research studies Previously collected tissue samples are also studied in the laboratory Samples are examined for DNA adduct levels Estrogen receptor α and β are assessed by immunohistochemistry IHC HER2 expression and amplification are measured by chromogenic in situ hybridization IHC and DNA-polymerase chain reaction PCR-single-stranded conformational polymorphism assay are used to analyze p53 mutations RAS mutations are analyzed with restriction fragment length polymorphism-PCR assay Polycyclic aromatic hydrocarbons and 4-aminobiphenyl-DNA damage are assessed by IHC and immunofluorescence Matrix-assisted laser desorptionionization time of flight mass spectrometry is used to genotype polymorphisms including CYP1A1 CYP1B1 GSTM1 GSTP1 MPO NAT-1 NAT-2 CYP19 CYP17 SULT1A1
Patients are followed annually for up to 5 years
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study female and male smoker strata closed to accrual as of 71507
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0424 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |