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Study of Biomarkers in Tissue Samples From Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
cytogenetic analysis
microarray analysis
mutation analysis
immunohistochemistry staining method
immunologic technique
mass spectrometry
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • Tumor tissue available

  • The following clinical information must be known:

    • ErbB2 status
    • Nodal status
    • Percent S phase

  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Post-translational modifications of estrogen-related receptor alpha (ERRα1) that are responsible for ERRα1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes
    Production of a panel of monoclonal antibodies to ERRα1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor
    Validation of the utility for immunohistochemistry (IHC) assays of some of the ERRα-specific sera by performing IHC and quantitative real-time PCR on some primary breast carcinomas
    Correlation of the results of IHC studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to ERRα1, ERRα1 status, currently assayed biomarkers, and course of treatment with patient outcomes

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2009
    Last Updated
    February 26, 2016
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01004796
    Brief Title
    Study of Biomarkers in Tissue Samples From Patients With Breast Cancer
    Official Title
    Estrogen-Related Receptor Alpha As A Novel Biomarker For Breast Cancer
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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 tissue samples from patients with breast cancer.
    Detailed Description
    OBJECTIVES: Identify by mass spectroscopy and site-specific mutagenesis the post-translational modifications of estrogen-related receptor alpha (ERRα1) that are responsible for ERRα1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes in tumors of patients with breast cancer. Produce a panel of monoclonal antibodies to ERRα1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor in these patients. Validate the utility for immunohistochemistry (IHC) assays of some of the ERRα-specific sera by performing IHC and quantitative real-time PCR on some primary breast carcinomas. Correlate the results of IHC studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to ERRα1, ERRα1 status, currently assayed biomarkers, and course of treatment with patient outcomes. OUTLINE: Breast tumor tissue samples are obtained from a tissue bank in the form of frozen tumors and paraffin-embedded sections on microarray blocks. Monoclonal antibodies (MOABs) to ERRα1 are produced using antigens in these tissue samples and immunohistochemical studies are performed using the MOABs. Cytogenetic studies are performed on DNA purified from these tissue samples.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast cancer

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    cytogenetic analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    microarray analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    mutation analysis
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Other
    Intervention Name(s)
    immunologic technique
    Intervention Type
    Other
    Intervention Name(s)
    mass spectrometry
    Primary Outcome Measure Information:
    Title
    Post-translational modifications of estrogen-related receptor alpha (ERRα1) that are responsible for ERRα1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes
    Title
    Production of a panel of monoclonal antibodies to ERRα1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor
    Title
    Validation of the utility for immunohistochemistry (IHC) assays of some of the ERRα-specific sera by performing IHC and quantitative real-time PCR on some primary breast carcinomas
    Title
    Correlation of the results of IHC studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to ERRα1, ERRα1 status, currently assayed biomarkers, and course of treatment with patient outcomes

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of breast cancer Tumor tissue available The following clinical information must be known: ErbB2 status Nodal status Percent S phase Hormone receptor status: Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Menopausal status not specified PRIOR CONCURRENT THERAPY: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janet E. Mertz, PhD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Biomarkers in Tissue Samples From Patients With Breast Cancer

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