Discordant HER2/Neu Status of Breast Cancer.

September 14, 2013 updated by: AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand

Discordant HER2/Neu Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.

The purpose of this study is to determine discordant HER2/neu 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

HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining. In the cases of equivocal result of IHC, FISH test were performed.

The result of HER2/neu 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

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • National Cancer Institute , Thailand.

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 70 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Primary Breast Tumor
Primary breast tumor were test for HER2/neu status.
Axillary Lymph Nodes.
Axillary Lymph Nodes were tested for HER2/neu status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of HER2/neu status between primary breast tumor and axillary lymph nodes
Time Frame: up to 1 year
Association of HER2/neu status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Thailand

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

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

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 31, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 14, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30_2013RC_IN318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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