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Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer

Sponsor
Qingdao Central Hospital (Other)
Overall Status
Suspended
CT.gov ID
NCT01934478
Collaborator
(none)
30
Enrollment
1
Location
76.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Study on Human Epidermal Growth Factor 2 (Her2) Expression Changes in Human Breast Cancer After Radiotherapy
    Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    Dec 30, 2019
    Anticipated Study Completion Date :
    Dec 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Her2 changes during radiotherapy [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qingdao Central Hospital, Qingdao Cancer Hospital Qingdao Shandong China 266042

    Sponsors and Collaborators

    • Qingdao Central Hospital

    Investigators

    • Study Chair: ketao lan, M.D., Qingdao Health Bereau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Youxin Ji, Chief, Department of Oncology, Qingdao Central Hospital
    ClinicalTrials.gov Identifier:
    NCT01934478
    Other Study ID Numbers:
    • QCH20130823-2
    First Posted:
    Sep 4, 2013
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Oct 1, 2015
    Keywords provided by Youxin Ji, Chief, Department of Oncology, Qingdao Central Hospital
    Breast
    Cancer
    Human Epidermal Growth Factor 2 (Her2)
    irradiation
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Feb 14, 2018