UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013763 |
|---|---|
| Receipt number | R000016063 |
| Scientific Title | The genetic screening to the hereditariness breast cancer high risk group |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/04/19 14:44:41 |
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Basic information
Public title
The genetic screening to the hereditariness breast cancer high risk group
Acronym
The genetic screening to the hereditariness breast cancer high risk group
Scientific Title
The genetic screening to the hereditariness breast cancer high risk group
Scientific Title:Acronym
The genetic screening to the hereditariness breast cancer high risk group
Region
| Japan |
Condition
Condition
The hereditariness breast cancer high risk group
Classification by specialty
| Surgery in general | Breast surgery | Obstetrics and Gynecology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The genetic screening to the hereditariness breast cancer high risk group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The diagnosis of the BRCA gene positive case
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The hereditariness breast cancer high risk group
Key exclusion criteria
The hereditariness breast cancer low risk group
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kitada |
Organization
Asahikawa Medical University
Division name
Breast Disease Center
Zip code
Address
Midorigaoka-Higashi 2-1-1-1,Asahikawa, Hokkaido, Japan
TEL
0166-69-3290
k1111@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Onishi |
Organization
Asahikawa Medical University
Division name
Respiratory Center
Zip code
Address
Midorigaoka-Higashi 2-1-1-1Asahikawa, Hokkaido, Japan
TEL
0166-69-3290
Homepage URL
http://www.asahikawa-med.ac.jp/hospital/respi/
k-onishi@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Breast Disease Center, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.asahikawa-med.ac.jp/hospital/respi/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
It does a genetic screening to the gene breast cancer high risk case.
It does the positive case an active treatment or a thorough follow-up.
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
Preinitiation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 04 | Month | 19 | Day |
Last modified on
| 2014 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016063
