- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943032
Discordant Hormonal Status of Breast Cancer.
September 19, 2013 updated by: AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand
Discordant Hormonal Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.
The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Hormonal status between primary breast tumor and axillary lymph node were analyzed.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok
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Ratchathewi, Bangkok, Thailand, 10400
- National Cancer Institute, Thailand.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Breast Cancer Patients Stage I,II and III.
Description
Inclusion Criteria:
- Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.
Exclusion Criteria:
- Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Primary Breast Tumor
Immunohistochemical staining of paraffin embedded tissue blocks of primary breast tumor for estrogen and progesterone receptors was performed.
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Axillary Lymph Nodes.
Immunohistochemical staining of paraffin embedded tissue blocks of axillary lymph nodes for estrogen and progesterone receptors was performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association of hormonal status between primary breast tumor and axillary lymph nodes
Time Frame: Up to 1 year
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Association of estrogen and progesterone status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test
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Up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
- Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
September 10, 2013
First Submitted That Met QC Criteria
September 11, 2013
First Posted (Estimate)
September 16, 2013
Study Record Updates
Last Update Posted (Estimate)
September 20, 2013
Last Update Submitted That Met QC Criteria
September 19, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC 196/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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