UMIN-CTR Clinical Trial

Basic information
Public title	A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
Acronym	A Safety Evaluation of RRM for HBOC
Scientific Title	A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
Scientific Title:Acronym	A Safety Evaluation of RRM for HBOC
Region	Japan

Condition
Condition	Hereditary Breast and Ovarian Cancer Syndrome
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To explore safety of RRM for HBOC
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of complications related RRM within 3 months.
Key secondary outcomes	Clinico-pathological characteristics and patients' background of primary breast cancer resected by RRM Incidence and histological characteristics of occult breast cancer for RRM. Exploratory outcome: Incidence of local recurrence and metastatic sites.

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	80 years-old >=
Gender	Female
Key inclusion criteria	A woman diagnosed has a BRCA1 or BRCA2 mutation, without breast cancer occurrence. Performance status (ECOG scale): 0-2 Duration of survival is expected more than 3 months. Written informed consent.
Key exclusion criteria	The presence of other active cancers (synchronous double cancers or metachronous double cancers required interventions). The presence of severe symptomatic diseases or active infectious disease. Physicians concludes that the patient participation on this study is inappropriate.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Goro Middle name Last name Kutomi
Organization	Sapporo Medical University Hospital
Division name	Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	kutomi@sapmed.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Shima
Organization	Sapporo Medical University Hospital
Division name	Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	simahiro@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization	none
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	Sapporo Medical University
Address	S1, W16, Chuo-ku, Sapporo
Tel	011-611-2111(31460)
Email	simahiro@sapmed.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	2018 Year 11 Month 26 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date	2018 Year 11 Month 26 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	2018 Year 11 Month 26 Day
Last modified on	2019 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039895