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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00913 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| W81XWH-11-1-0500 | Other Identifier | Dept of Defense | |
| 2014-002 | Other Identifier | Barbara Ann Karmanos Cancer Institute | |
| P30CA022453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and help doctors to tailor treatment to target the specific mutations.
PRIMARY OBJECTIVES:
I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.
SECONDARY OBJECTIVES:
I. To estimate the percentage of patients in whom genomic analysis can be performed.
II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.
OUTLINE:
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (comprehensive genomic analysis) | Experimental | Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytology specimen collection procedure | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients receiving therapy based on genomic analyses among all eligible patients | Will be estimated with 95% confidence interval (CI) using the Wilson's method. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1 | Response rate will be estimated with 95% Wilson's CI. | Up to 2 years |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerold Bepler, M.D. | Contact | (313) 576-8665 |
| Name | Affiliation | Role |
|---|---|---|
| Gerold Bepler, M.D. | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KCI at McLaren Bay Region | Recruiting | Bay City | Michigan | 48708 | United States |
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This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis.
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| laboratory biomarker analysis | Other | Correlative studies |
|
PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
| Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years |
| Overall survival (OS) | Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data. | From date of registration to up to 2 years |
| KCI at Mclaren Bloomfield Hills | Recruiting | Bloomfield Hills | Michigan | 48302 | United States |
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| KCI At McLaren Clarkston | Recruiting | Clarkston | Michigan | 48346 | United States |
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| Barbara Ann Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| KCI at McLaren Flint | Recruiting | Flint | Michigan | 48532 | United States |
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| KCI at McLaren Greater Lansing, Mid Michigan Physicians | Recruiting | Lansing | Michigan | 48910 | United States |
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| KCI at McLaren Lapeer Region | Recruiting | Lapeer | Michigan | 48446 | United States |
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| KCI at McLaren Macomb | Recruiting | Mount Clemens | Michigan | 48043 | United States |
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| KCI at McLaren Central Michigan | Recruiting | Mount Pleasant | Michigan | 48858 | United States |
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| KCI at Northern Michigan | Recruiting | Petoskey | Michigan | 49770 | United States |
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| KCI at McLaren Port Huron | Recruiting | Port Huron | Michigan | 48060 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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