UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036134 |
|---|---|
| Receipt number | R000041167 |
| Scientific Title | A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2021/09/08 11:49:13 |
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Basic information
Public title
A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Acronym
A Safety evaluation of RRM for BRCA1/2 pathological variant carriers
Scientific Title
A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Scientific Title:Acronym
A Safety evaluation of RRM for BRCA1/2 pathological variant carriers
Region
| Japan |
Condition
Condition
BRCA1/2 pathological variant carriers
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore safety of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of risk-reducing mastectomy
Key secondary outcomes
1)Incidence of breast cancer after risk-reducing mastectomy
2)Incidence of complications related risk-reducing mastectomy
3)Incidence of occult breast cancer and precancerous lesions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Surgery : Risk-Reducing mastectomy
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)BRCA1/2 pathological variant carriers
2)Woman without ipsilateral breast cancer occurrence
3)Woman who can visit our hospital to a follow-up survey after surgery
4)Informed consent
Key exclusion criteria
1)Pregnant woman or possibility for pregnant woman
2)Physicaians concludes that the patient participation on this study in inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Sugie |
Organization
Kansai medical university hospital
Division name
Department of surgery
Zip code
573-0101
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
0728040101
hirotsugu_yanai@hotmail.com
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Yanai |
Organization
Kansai Medical University hospital
Division name
Department of surgery
Zip code
573-0101
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
0728040101
Homepage URL
hirotsugu_yanai@hotmail.com
Sponsor or person
Institute
Kansai medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
2-5-1, Shinmachi
Tel
0728040101
rinriirb@hirakata.kmu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041167
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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