NCT01934478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

9.4 years

First QC Date

August 23, 2013

Last Update Submit

March 27, 2023

Conditions

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Keywords

BreastCancerHuman Epidermal Growth Factor 2 (Her2)irradiation

Outcome Measures

Primary Outcomes (1)

  • Her2 changes during radiotherapy

    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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

study population is among advanced Chinese breast cancer patient.

You may qualify if:

  • 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

You may not qualify if:

  • no radiotherapy indication
  • patient refuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • ketao lan, M.D.

    Qingdao Health Bereau

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Oncology

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 4, 2013

Study Start

August 1, 2013

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

CN(1)