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Trial Title:
Study of Biomarkers in Tissue Samples From Patients With Breast Cancer
NCT ID:
NCT01004796
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
Study type:
Observational
Overall status:
Unknown status
Intervention:
Intervention type:
Genetic
Intervention name:
cytogenetic analysis
Intervention type:
Genetic
Intervention name:
microarray analysis
Intervention type:
Genetic
Intervention name:
mutation analysis
Intervention type:
Other
Intervention name:
immunohistochemistry staining method
Intervention type:
Other
Intervention name:
immunologic technique
Intervention type:
Other
Intervention name:
mass spectrometry
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
120 Years
Healthy volunteers:
No
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01004796