Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
Recruitment status was Not yet recruiting
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research studies tumor tissue samples from patients with early- stage non-small cell lung cancer.
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Other: medical chart review
|Official Title:||Validation of Molecular Prognostic Tests in NSCLC|
- Development and validation of a molecular prognostic signature for worse or good survival [ Designated as safety issue: No ]
- 36-month survival rate for each risk group using Kaplan-Meier survival analyses [ Designated as safety issue: No ]
- Statistical significance of the association between a specific signature and disease-free survival or overall survival [ Designated as safety issue: No ]
- Validation of prognostic signatures and classifiers for stage IB and stage II NSCLC [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
- To develop and validate a clinically useful molecular prognostic signature based on RNA-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.
- To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.
- To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage-specific prognostic classifiers.
- To determine the relevant statistical features, including accuracy of predicting overall survival, cancer-specific survival, and disease-free survival at 3 and 5 years, for each of the prognostic classifiers validated.
- To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.
OUTLINE: This is a multicenter study.
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Affymetrix Gene Profiling Array (cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR). Results are then compared and validated with molecular prognostic signatures that already exist, patients demographics, clinical characteristics, treatment received, and outcomes. A new prognostic signature is then constructed and incorporated into combined classifiers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517971
|Principal Investigator:||Raphael Bueno, MD||Dana-Farber/Brigham and Women's Cancer Center|