UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047013 |
|---|---|
| Receipt number | R000053603 |
| Scientific Title | Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/26 14:09:32 |
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Basic information
Public title
Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers
Acronym
Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers
Scientific Title
Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers
Scientific Title:Acronym
Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Safety assessment of RRM for healthy BRCA1/2 mutation carriers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of surgery
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Healthy BRCA1 / 2 gene mutation carrier
2. After genetic counseling at our hospital
3. Proven to have a BRCA1 or BRCA2 gene mutation
4. Women who are 20 years of age or older on the date of consent acquisition.
5. Fully understanding risk-reducing mastectomy and wish to have risk-reducing mastectomy.
6. ECOG Performance Status (PS) is 0
7. Those that retain the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.)
1) White blood cells: 3000 / mm3 or more, less than 12,000 / mm3
2) Hemoglobin: 9.0 g / dl or more
3) Platelets: 100,000 / mm3 or more
4) Total bilirubin: less than 2.0 mg / dL
5) AST, ALT: Facility normal value upper limit x 2 or less
6) Serum creatinine: Within normal facility normal value x 1.5
7) ECG, vital capacity: Those with cardiopulmonary function that can be operated by general anesthesia
The inspection data in 1) -7) above shall be within 60 days before the date of consent acquisition.
8. Written consent from the subject to participate in this study
Key exclusion criteria
1. Have active cancer
2. Pregnant and lactating women
3. Have an infectious disease that requires systemic treatment
4. Researchers have determined that participation in this study is inappropriate
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Maeda |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7550085
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
nsampei@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.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
山口大学大学院 消化器・腫瘍外科学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety assessment of RRM for healthy BRCA1/2 carriers
Management information
Registered date
| 2022 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053603
