UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of risk reducing salpingo-oophorectomy (RRSO) in patients with pathological variants of the BRCA1/2 gene
Acronym	Clinical Study on RRSO in HBOC Patients
Scientific Title	Clinical study of risk reducing salpingo-oophorectomy (RRSO) in patients with pathological variants of the BRCA1/2 gene
Scientific Title:Acronym	Clinical Study on RRSO in HBOC Patients
Region	Japan

Condition
Condition	Hereditary Breast and Ovarian Cancer, HBOC
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This is a clinical study to evaluate the efficacy, safety, and psychosocial effects of RRSO in patients who have already been genetically diagnosed with pathological mutations in the BRCA1/2 gene of the germ line, confirmed as hereditary breast cancer ovarian cancer ovarian syndrome (HBOC), and have not yet developed ovarian cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Preventive effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in patients with pathological mutations in the germline BRCA1/2 genes and a confirmed diagnosis of hereditary breast and ovarian cancer syndrome (HBOC). Data will be collected on the time to occurrence. The time to occurrence is defined as the period from the date of registration to the date of occurrence or death of ovarian cancer, fallopian tube cancer, or peritoneal cancer.
Key secondary outcomes	Presence or absence of ovarian cancer (occult cancer) detected at the time of RRSO Evaluation of the surgery (amount of blood loss, operative time, complications, etc.) Evaluation of postoperative QOL by RRSO (menopause score, QOL-ACD, etc.) Adverse events within 3 months after surgery Medical economic evaluation

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	Maneuver
Interventions/Control_1	Two clinical geneticists or two obstetricians/gynecologists (one from the Department of Obstetrics and Gynecology and the other from a department not directly involved in the study) will separately provide genetic counseling to eligible patients, and will take sufficient time to explain the purpose and methods of RRSO, the interpretation and limitations of the pathology results, and alternatives if the patient does not participate in the study, and obtain written consent. At the time of surgery, ascites as well as ovaries and fallopian tubes will be collected, and postoperative ascitic fluid cytology will be performed along with detailed pathological examination of the removed tissue. Surgically removed bilateral adnexa should be pathologically examined for malignant findings.
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	1. Mutation in the BRCA1 or BRCA2 gene of germ line cells 2. Have not yet developed ovarian cancer 3. ECOG PS of 0-1 4. Age between 20 and 80 years old The patient must have given written consent.
Key exclusion criteria	1. Patients with active multiple cancers (concurrent multiple cancers requiring therapeutic intervention) 2. Patients with a group of diseases that present severe systemic symptoms or active infectious diseases. 3. Any other cases that are deemed inappropriate by the physician in charge.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Saito
Organization	Sapporo Medical University
Division name	Obstetrics and Gynecology
Zip code	060-8543
Address	South 1 West 16, Chuo-ku, Sapporo
TEL	0116112111
Email	tsaito@sapmed.ac.jp

Public contact
Name of contact person	1st name Tasuku Middle name Last name Mariya
Organization	Sapporo Medical University
Division name	Obstetrics and Gynecology
Zip code	060-8543
Address	South 1 West 16, Chuo-ku, Sapporo
TEL	0116112111
Homepage URL
Email	mariya.tasuku@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	None
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 trial center, Sapporo Medical University
Address	South 1 West 16, Chuo-ku, Sapporo 060-8543
Tel	0116112111
Email	ji-rskk@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	2021 Year 01 Month 06 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 09 Month 13 Day
Date of IRB	2018 Year 09 Month 13 Day
Anticipated trial start date	2018 Year 09 Month 13 Day
Last follow-up date	2030 Year 03 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	2021 Year 01 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048992