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NCT01132560 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
A Correlative Science Study for ECOG E5194

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01132560
Other study ID # CDR0000671157
Secondary ID ECOG-E5194T1
Status Completed
Phase N/A
First received May 26, 2010
Last updated May 16, 2017
Start date March 5, 2010
Est. completion date April 5, 2010

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 500
Est. completion date April 5, 2010
Est. primary completion date April 5, 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Ipsilateral local failure (first event of invasive or DCIS recurrence) 1 month
Secondary Contralateral breast cancer (invasive or DCIS) 1 month
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