Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01517971|
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment|
|Lung Cancer||Other: laboratory biomarker analysis|
I. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (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.
I. 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.
II. 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.
III. 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.
IV. 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.
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).
|Study Type :||Observational|
|Estimated Enrollment :||1060 participants|
|Official Title:||Validation of Molecular Prognostic Tests in NSCLC|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2100|
Ancillary-correlative (whole-genome expression)
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR.
Other: laboratory biomarker analysis
- Recurrence [ Time Frame: up to 36 months ]
- Cancer specific survival [ Time Frame: Up to 36 months ]
- Disease-free survival [ Time Frame: up to 36 months ]
- Overall survival [ Time Frame: up to 36 months ]
- Probability of death due to other causes [ Time Frame: up to 36 months ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517971
|Contact: Raphael Bueno, MD||617-732-8148|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Raphael Bueno, MD 617-732-8533|
|Study Chair:||Raphael Bueno, MD||Brigham and Women's Cancer Center|