Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer

This study has been withdrawn prior to enrollment.
(not "applicable clinical trial")
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00899639
First received: May 9, 2009
Last updated: May 27, 2015
Last verified: May 2015
  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 looking at tumor tissue samples from patients with early-stage breast cancer.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation of Oncotype Dx With Image Features and Molecular Characteristics of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay [ Designated as safety issue: No ]
  • Histological image-based analysis in stratifying estrogen receptor-positive breast cancer into prognostic categories [ Designated as safety issue: No ]
  • Identification of new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis estrogen receptor-positive breast cancers [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To characterize differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay (a reverse transcriptase-PCR-based assay).
  • To develop a computer-aided design (CAD)-based system of analysis of digitized histological images that would perform as well as Oncotype Dx assay in stratifying estrogen receptor-positive (ER+) breast cancer into prognostic categories.
  • To identify new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis ER+ breast cancers.

OUTLINE: Patients who had Oncotype Dx assay (a reverse transcriptase-PCR-based assay) performed for their breast cancer are identified by review of medical records. Diagnostic H&E stained tumor tissue samples are reviewed by a pathologist. Relevant pathologic features of the tumor (size, stage, grade, estrogen receptor, progesterone receptor, and HER2 staining) and linked Oncotype Dx score are recorded.

The H&E stained tumor tissue samples are scanned to create high-resolution digital images. The images from each tissue sample are subjected to image analysis algorithms to identify sets of image features that most clearly separate tumors with low recurrence scores from those with high recurrence scores.

Unstained paraffin sections from each tumor tissue sample, when available, are processed using IHC to analyze PI3-kinase signaling pathway (PTEN expression). Staining for other components of the PI3-kinase signaling pathway, phospo-AKT, and other proteins of interest is also performed. DNA is extracted from the samples and subjected to pyrosequencing analysis on exons 9 and 20 of PI3KCA. Sequencing of other relevant potential oncogenes, such as AKT, is also performed. Statistical analysis is performed to look for a correlation between Oncotype Dx scores and the presence of PI3KCA mutations and/or loss of PTEN expression.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ER+ breast cancer with associated Oncotype Dx scores
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of early-stage breast cancer for which an Oncotype Dx assay has been performed
  • Must have diagnostic H&E stained tumor tissue samples available
  • Hormone receptor status:

    • Estrogen receptor-positive tumor

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00899639

Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Shridar Ganesan, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00899639     History of Changes
Other Study ID Numbers: 000809  P30CA072720  CDR0000600231  CINJ-0220080120 
Study First Received: May 9, 2009
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
estrogen receptor-positive breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on February 11, 2016