Assessment of Candidate Protein Expression in Breast Cancer Specimens

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00918892
First received: June 9, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.


Condition Intervention
Breast Cancer
Genetic: gene expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Assessment of Candidate Protein Expression in Human Breast Cancer Specimens

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Differential expression of candidate genes between normal and cancer breast tissues [ Time Frame: non-applicable ] [ Designated as safety issue: No ]
    Approximately 5 slides of each tumor will be collected to provide sufficient samples for replicate staining, if necessary, as well as a staining for a positive control


Biospecimen Retention:   Samples With DNA

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.


Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: gene expression analysis
    Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
    Other: immunohistochemistry staining method
    Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
    Other: laboratory biomarker analysis
    Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
Detailed Description:

OBJECTIVES:

  • To determine if candidate genes display differential expression between normal and cancer breast tissues.

OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • Tissue samples available
  • Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:

    • Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
    • ER-positive/PR-positive/ HER2-positive by FISH
    • ER-negative/PR-negative/HER2-positive
    • ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)

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: NCT00918892

Contacts
Contact: Ruth Keri, PhD 216-368-3495 ruth.keri@case.edu

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Ruth A. Keri, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00918892     History of Changes
Other Study ID Numbers: CASE1108, P30CA043703, CASE1108, CASE-1108-CC504
Study First Received: June 9, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
triple-negative breast cancer
HER2-negative breast cancer
HER2-positive breast cancer

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

ClinicalTrials.gov processed this record on July 29, 2014