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Assessment of Candidate Protein Expression in Breast Cancer Specimens

This study is currently recruiting participants.
Verified August 2017 by Case Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918892
First Posted: June 11, 2009
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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: Observational Model: Other
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 ]
    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
Actual Study Start Date: April 24, 2008
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Inclusion 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

Exclusion Criteria:

  • There are no exclusion criteria in this protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918892


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

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

Additional Information:
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00918892     History of Changes
Other Study ID Numbers: CASE1108
P30CA043703 ( U.S. NIH Grant/Contract )
CASE1108 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-1108-CC504 ( Other Identifier: Cancer Center IRB )
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: August 4, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Progesterone
Estrogens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs