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Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ

A Correlative Science Study for ECOG E5194

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01132560
Enrollment
500
Registered
2010-05-28
Start date
2010-03-05
Completion date
2010-04-05
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

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).

Interventions

GENETICRNA analysis
GENETICgene expression analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Ipsilateral local failure (first event of invasive or DCIS recurrence)1 month

Secondary

MeasureTime frame
Contralateral breast cancer (invasive or DCIS)1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026