Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
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|ClinicalTrials.gov Identifier: NCT01132560|
Recruitment Status : Completed
First Posted : May 28, 2010
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 studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis|
- To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.
OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||A Correlative Science Study for ECOG E5194|
|Actual Study Start Date :||March 5, 2010|
|Actual Primary Completion Date :||April 5, 2010|
|Actual Study Completion Date :||April 5, 2010|
- Ipsilateral local failure (first event of invasive or DCIS recurrence) [ Time Frame: 1 month ]
- Contralateral breast cancer (invasive or DCIS) [ 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): NCT01132560
|Principal Investigator:||Lawrence J. Solin, MD, FACR||Abramson Cancer Center of the University of Pennsylvania|