- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132560
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
A Correlative Science Study for ECOG E5194
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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Diagnosis of ductal breast carcinoma in situ
Enrolled on clinical trial ECOG-E5194
- Local surgery without radiotherapy
- Treated or not treated with tamoxifen
- Available tissue samples
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ipsilateral local failure (first event of invasive or DCIS recurrence)
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Contralateral breast cancer (invasive or DCIS)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lawrence J. Solin, MD, FACR, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000671157
- ECOG-E5194T1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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