Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
NCT ID: NCT01132560
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2010-03-05
2010-04-05
Brief Summary
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PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.
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Detailed Description
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* 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).
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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RNA analysis
gene expression analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Lawrence J. Solin, MD, FACR
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Other Identifiers
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ECOG-E5194T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000671157
Identifier Type: -
Identifier Source: org_study_id
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