- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934478
Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer
March 27, 2023 updated by: Youxin Ji, Qingdao Central Hospital
Study on Human Epidermal Growth Factor 2 (Her2) Expression Changes in Human Breast Cancer After Radiotherapy
Based on fundamental study (in Vitro and in Vivo, Pro.
Jianjian Li), Her2 expression would be changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or up.
The propose of this study is to reveal the irradiation result on Her2 expression in human breast cancer.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
5
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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Shandong
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Qingdao, Shandong, China, 266042
- Qingdao Central Hospital, Qingdao Cancer Hospital
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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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
study population is among advanced Chinese breast cancer patient.
Description
Inclusion Criteria:
- histological confirmed advanced breast cancer
- cancer sample can be obtained by fine needle biopsy
- IHC and FISH confirmed Her2 negative
- radiotherapy indication for local residual cancer
Exclusion Criteria:
- no radiotherapy indication
- patient refuse
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Her2 changes during radiotherapy
Time Frame: every week up to 6 weeks
|
biopsy is obtained by fine needle biopsy,Her2 is checked by Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH).
|
every week up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: ketao lan, M.D., Qingdao Health Bereau
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
August 1, 2013
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
August 23, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QCH20130823-2
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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