Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT01132560
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- 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 Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ipsilateral local failure (first event of invasive or DCIS recurrence) 1 month
- Secondary Outcome Measures
Name Time Method Contralateral breast cancer (invasive or DCIS) 1 month