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Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Tissue Collection, Lung Cancer, Non-Small Cell Lung Cancer, Early Stage Lung Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals.
Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.
The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.
Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.
The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.
Detailed Description
Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
- Must have resectable disease and complete surgical resection planned
- Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
- No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
- Tumor specimen samples must be collected within 1 hour of surgery
- Patient must be at least 18 years of age
- Patient must sign and date an approved study consent form
Exclusion Criteria:
- Patients with psychiatric or addictive disorders that would preclude obtaining study consent
- Informed consent obtained the same day as surgery
- Absence of histological diagnosis of lung cancer
- Known infectious disease
- History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis
- New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
- Must have resectable disease and complete surgical resection planned
- Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
- No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
- Tumor specimen samples must be collected within 1 hour of surgery
- Patient must be at least 18 years of age
- Patient must sign and date an approved study consent form
Exclusion Criteria:
- Patients with psychiatric or addictive disorders that would preclude obtaining study consent
- Informed consent obtained the same day as surgery
- Absence of histological diagnosis of lung cancer
- Known infectious disease
- History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis
Locations
Cardio-Thoracic Surgeons, P. C.
Birmingham, Alabama, United States
University of Alabama at Birmingham
Status: Recruiting
Birmingham, Alabama, United States
Martin Memorial Treasure Coast Surgeons
Status: Not yet recruiting
Stuart, Florida, United States
Baptist Hospital East
Status: Recruiting
Louisville, Kentucky, United States
Massachusetts General Hospital
Status: Not yet recruiting
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Status: Recruiting
Pittsburgh, Pennsylvania, United States
Centennial Thoraic Surgeons
Status: Not yet recruiting
Nashville, Tennessee, United States
Status: Recruiting
Start Date
October 2011
Sponsors
Precision Therapeutics
Source
Precision Therapeutics
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page