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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 26, 2010
Last updated: July 7, 2010
Last verified: May 2010

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.

Condition Intervention
Breast Cancer
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: A Correlative Science Study for ECOG E5194

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ipsilateral local failure (first event of invasive or ductal carcinoma in situ [DCIS] recurrence)

Secondary Outcome Measures:
  • Contralateral breast cancer (invasive or DCIS)

Estimated Enrollment: 500
Study Start Date: June 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • To validate the prognostic utility of the Oncotype DX Recurrence Score® assay in tissue samples from patients with ductal breast carcinoma in situ 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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Menopausal status not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01132560

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Lawrence J. Solin, MD, FACR Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01132560     History of Changes
Other Study ID Numbers: CDR0000671157
Study First Received: May 26, 2010
Last Updated: July 7, 2010

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary processed this record on April 25, 2017