Breast CancerNCT01004796
Study of Biomarkers in Tissue Samples From Patients With Breast Cancer
An observational study of Breast Cancer, run by University of Wisconsin, Madison.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cytogenetic analysis, microarray analysis and mutation analysis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: Estrogen-Related Receptor Alpha As A Novel Biomarker For Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- cytogenetic analysis, microarray analysis, mutation analysis, immunohistochemistry staining method, immunologic technique
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytogenetic analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
immunologic techniqueOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Janet E. Mertz, PhD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004796
- Sponsor's protocol ID
- CDR0000357299
- Other IDs
- P30CA014520, WCCC-CO-TEMP
- Status last verified
- Feb 2016
- First submitted
- 29 Oct 2009
- Last updated
- 29 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen-Related Receptor Alpha As A Novel Biomarker For Breast Cancer
- ClinicalTrials.gov ID
- NCT01004796
- Acronym / sponsor ID
- CDR0000357299
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytogenetic analysis | Genetic | – |
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
| mass spectrometry | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet E. Mertz, PhD study chair
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.