Status:
UNKNOWN
Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
Lead Sponsor:
Precision Therapeutics
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 w...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01450553
Start Date
October 1 2011
Last Update
January 11 2012
Active Locations (7)
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1
Cardio-Thoracic Surgeons, P. C.
Birmingham, Alabama, United States
2
University of Alabama at Birmingham
Birmingham, Alabama, United States
3
Martin Memorial Treasure Coast Surgeons
Stuart, Florida, United States
4
Baptist Hospital East
Louisville, Kentucky, United States