- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450553
Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Recruiting
- Cardio-Thoracic Surgeons, P. C.
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Birmingham, Alabama, United States
- Not yet recruiting
- University of Alabama at Birmingham
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Florida
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Stuart, Florida, United States
- Recruiting
- Martin Memorial Treasure Coast Surgeons
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Kentucky
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Louisville, Kentucky, United States
- Not yet recruiting
- Baptist Hospital East
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Massachusetts
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Boston, Massachusetts, United States
- Recruiting
- Massachusetts General Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Not yet recruiting
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, United States
- Recruiting
- Centennial Thoraic Surgeons
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD-110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer
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WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
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University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
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Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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Genelux CorporationNewsoara Biopharma Co., Ltd.Not yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Advanced Non-squamous Non-small-cell Lung Cancer | Non-small Cell Lung Cancer Stage IV | Metastatic Squamous Non-Small Cell Lung Carcinoma | Non-small Cell Lung Cancer Recurrent | Metastatic Non-squamous Non Small Cell Lung Cancer and other conditions