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Clinical Trials/NCT01132560
NCT01132560
Completed
Not Applicable

A Correlative Science Study for ECOG E5194

ECOG-ACRIN Cancer Research Group0 sites500 target enrollmentMarch 5, 2010
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
ECOG-ACRIN Cancer Research Group
Enrollment
500
Primary Endpoint
Ipsilateral local failure (first event of invasive or DCIS recurrence)
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 5, 2010
End Date
April 5, 2010
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
ECOG-ACRIN Cancer Research Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ipsilateral local failure (first event of invasive or DCIS recurrence)

Time Frame: 1 month

Secondary Outcomes

  • Contralateral breast cancer (invasive or DCIS)(1 month)

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