UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030431 |
|---|---|
| Receipt number | R000034746 |
| Scientific Title | Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2017/12/16 18:55:39 |
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Basic information
Public title
Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Acronym
Risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Scientific Title
Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Scientific Title:Acronym
Risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Region
| Japan |
Condition
Condition
Breast cancer
Ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm feasibility of risk-reducing salpingo-oophorectomy and risk-reducing mastectomy with breast reconstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of surgical complications
Key secondary outcomes
Preventive efficacy of breast and ovarian cancer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Risk-reducing salpingo-oophorectomy
Risk-reducing mastectomy with breast reconstruction
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Carriers of deleterious mutation of BRCA1 or BRCA2
Key exclusion criteria
Non-carriers of deleterious mutation of BRCA1 or BRCA2
Patients who has not received genetic testing for BRCA1 or BRCA2
Carriers who dose not hope to receive risk-reducing surgery
Carriers who dose not give her consent for risk-reducing surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tamaki |
Organization
Osaka International Cancer Institute
Division name
Breast and endocrine surgery
Zip code
Address
3-1-69, Otemae, Tyuo-ku, Osaka
TEL
06-6945-1181
tamaki-ya@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tamaki |
Organization
Osaka International Cancer Institute
Division name
Breast and endocrine surgery
Zip code
Address
3-1-69, Otemae, Tyuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
tamaki-ya@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034746
