Clinical Trial: Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Correlative Science Study for ECOG E5194
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
- 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).
Sponsor: ECOG-ACRIN Cancer Research Group
Current Primary Outcome: Ipsilateral local failure (first event of invasive or DCIS recurrence) [ Time Frame: 1 month ]
Original Primary Outcome: Ipsilateral local failure (first event of invasive or DCIS recurrence)
Current Secondary Outcome: Contralateral breast cancer (invasive or DCIS) [ Time Frame: 1 month ]
Original Secondary Outcome: Contralateral breast cancer (invasive or DCIS)
Information By: Eastern Cooperative Oncology Group
Dates:
Date Received: May 26, 2010
Date Started: March 5, 2010
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017
