Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00897845|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: RNA analysis Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197.
- To define a set of significant genes as prognostic markers of recurrence.
- To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study.
- To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.
- To compare the prognostic value of selected genes with gene sets determined in this study.
OUTLINE: This is a multicenter study.
Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.
|Study Type :||Observational|
|Actual Enrollment :||2541 participants|
|Official Title:||Molecular Profiling of E2197 FFPE Samples Using a Custom 512 Breast Cancer Gene Set on the DASL Platform: Towards the Development of Predictive Gene Sets for Risk of Recurrence in Patients With Operable Breast Cancer Treated With Adjuvant Therapy|
|Actual Study Start Date :||June 17, 2008|
|Actual Primary Completion Date :||December 2, 2013|
|Actual Study Completion Date :||December 2, 2013|
- Correlation of results with Outcome [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897845
|Study Chair:||Brian Leyland-Jones, MD||Emory University|