UMIN-CTR Clinical Trial

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
Email	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
Email	nsampei@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053603