Radiotherapy Alternates Human Epidermal Growth Factor 2 (... | NCT01934478

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

NCT01934478

Sponsor

Qingdao Central Hospital

Status

Completed

Last Update Posted

Mar 29, 2023Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Aug 23, 2013

First Submission Date that Met QC Criteria

Aug 29, 2013

First Posted Date

Sep 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2023

Last Update Posted Date

Mar 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

study population is among advanced Chinese breast cancer patient.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ketao lan, M.D.	Qingdao Health Bereau	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qingdao Central Hospital, Qingdao Cancer Hospital		Qingdao	Shandong	266042	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided