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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01132560
First received: May 26, 2010
Last updated: July 7, 2010
Last verified: May 2010
  Purpose

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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Contralateral breast cancer (invasive or DCIS) [ Designated as safety issue: No ]

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

OBJECTIVES:

  • 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132560

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

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01132560     History of Changes
Other Study ID Numbers: CDR0000671157, ECOG-E5194T1
Study First Received: May 26, 2010
Last Updated: July 7, 2010
Health Authority: Unspecified

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
Adenocarcinoma
Breast Diseases
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014