Study of Biomarkers in Tissue Samples From Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Estrogen-Related Receptor Alpha As A Novel Biomarker For Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01004796
• Other study ID #: CDR0000357299
• Secondary ID: P30CA014520WCCC-
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2009
• Last updated: February 26, 2016

Study information

• Verified date: February 2016
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• cytogenetic analysis

• microarray analysis

• mutation analysis

Other:
• immunohistochemistry staining method

• immunologic technique

• mass spectrometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-translational modifications of estrogen-related receptor alpha (ERRa1) that are responsible for ERRa1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes			No
Primary	Production of a panel of monoclonal antibodies to ERRa1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor			No
Primary	Validation of the utility for immunohistochemistry (IHC) assays of some of the ERRa-specific sera by performing IHC and quantitative real-time PCR on some primary breast carcinomas			No
Primary	Correlation of the results of IHC studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to ERRa1, ERRa1 status, currently assayed biomarkers, and course of treatment with patient outcomes			No