Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer
Recruitment status was Not yet recruiting
RATIONALE: Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.
PURPOSE: This research studies protein in tumor samples from patients with non-small cell lung cancer.
Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: staining method
|Official Title:||Evaluation of a Novel Molecular NSCLC Classification System|
- Validation of a novel 4-protein signature's ability to subtype NSCLC [ Designated as safety issue: No ]
- NSCLC misclassification rate [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
- To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, CALGB 9761.
- To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
OUTLINE: Archived tumor tissue samples are marked for regions appropriate for incorporation into tissue microarray (TMA) and incubated with a cocktail of primary antibodies. Slides are then stained and a series of high-resolution monochromatic images are captured by the PM-2000 ™ microscope of each protein. Score of each specific protein is then calculated by Automated Quantitative Analysis (AQUA).
A board-certified pathologist with a clinical focus in lung cancer reviews the hematoxylin and eosin (H&E) and immunohistochemistry (IHC) slides and indicates the specific non-small cell lung cancer subtype. Results are then compared with the primary reference subtype captured by CALGB-9761 database.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415739
|Principal Investigator:||Daniel J. Boffa, MD||Smilow Cancer Hospital at Yale-New Haven|