UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054491 |
|---|---|
| Receipt number | R000062218 |
| Scientific Title | clinical trial of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/27 12:41:01 |
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Basic information
Public title
clinical trial of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers
Acronym
RRM
Scientific Title
clinical trial of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers
Scientific Title:Acronym
RRM
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer
Classification by specialty
| Breast surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Risk-reducing mastectomy (RRM) is performed on women with BRCA1/2 gene mutations. We will investigate the safety of the procedure and the frequency of postoperative complications (postoperative bleeding, wound infection).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers
Frequency of intraoperative and postoperative complications
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform a risk-reducing mastectomy if the patient requests it.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Women aged 18 years or older who have undergone genetic counseling and have a BRCA1/2 gene mutation as a result of genetic diagnosis.
2) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
3) To participate in this study, the patient's voluntary written consent has been obtained after sufficient informed consent, including explanation of alternative treatments. The decision was made based on the results of the genetic test and after thorough discussions with the patient and her family.
Key exclusion criteria
1) Surgery is not possible after normal preoperative examinations
2) Patients who are pregnant or may become pregnant
3) Patients who are judged by the research director or co-investigator to be unsuitable as research subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Kawaguchi |
Organization
Mie University hospital
Division name
breast center
Zip code
5148507
Address
Edobashi 2-174, Tsu City, Mie Pref, JAPAN
TEL
0592321111
k-mao@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Kimoto |
Organization
Mie University hospital
Division name
breast center
Zip code
5148507
Address
Edobashi 2-174, Tsu City, Mie Pref, JAPAN
TEL
0592321111
Homepage URL
k-mao@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University hospital, breast center
Institute
Department
Personal name
Funding Source
Organization
scholarship donation for breast center
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
Clinical Research and Development Center
Address
Edobashi 2-174, Tsu City, Mie Pref, JAPAN
Tel
0592321111
kk-sien@med.mie-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H2024-079
Org. issuing International ID_1
ethics committee of Mie University hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2024 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062218
