UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027908
Receipt No. R000031728
Scientific Title Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes
Date of disclosure of the study information 2017/08/01
Last modified on 2019/06/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes
Acronym Multicenter retrospective study for brain metastases from breast cancer
Scientific Title Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes
Scientific Title:Acronym Multicenter retrospective study for brain metastases from breast cancer
Region
Japan

Condition
Condition brain metastases
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the clinical outcomes (functional preservation, neurological death, and overall survival etc.) base on molecular subtypes of breast cancer in multicenter retrospective study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Loss of functional independence
Neurological death
Key secondary outcomes Overall survival, tumor control, tumor recurrence, radiation injury, distant recurrence

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Breast cancer patients with brain metastases treated by gamma knife surgery are included. Gamma knife surgery was completed until March 31, 2017. The genetic phenotype of breast cancer is mandatory.
Key exclusion criteria patients with undetermined genetic phenotype
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Higuchi
Organization Chiba University Graduate School of Medicine
Division name Department of Neurological Surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2158
Email yhiguchi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Aoyagi
Organization Chiba Cerebral and Cardiovascular Center
Division name Department of Neurosurgery
Zip code 290-0512
Address 575 Tsurumai, Ichihara city, Chiba, Japan
TEL 0436-88-3111
Homepage URL
Email kyo-tsuru@nifty.com

Sponsor
Institute Japanese Gamma Knife Society
Institute
Department

Funding Source
Organization ELEKTA RESEARCH FUND
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Graduate School of Medicine
Address 1-8-1 Inohana, Chuo-ku, Chiba
Tel 043-226-2158
Email yhiguchi@faculty.chiba-u.jp

Secondary IDs
Secondary IDs YES
Study ID_1 JLGK1702
Org. issuing International ID_1 Japanese Gamma Knife Society
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 413
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 05 Month 20 Day
Date of IRB
2017 Year 08 Month 01 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information none

Management information
Registered date
2017 Year 06 Month 23 Day
Last modified on
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.