UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044616 |
|---|---|
| Receipt number | R000050964 |
| Scientific Title | A feasibility study of Risk-Reducing Salpingo-Oophorectomy based on hereditary breast and ovarian cancer syndrome -associated gene mutations |
| Date of disclosure of the study information | 2021/06/22 |
| Last modified on | 2021/06/22 11:24:39 |
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Basic information
Public title
A feasibility study of Risk-Reducing Salpingo-Oophorectomy based on hereditary breast and ovarian cancer syndrome -associated gene mutations
Acronym
A feasibility study of Risk-Reducing Salpingo-Oophorectomy based on hereditary breast and ovarian cancer syndrome -associated gene mutations
Scientific Title
A feasibility study of Risk-Reducing Salpingo-Oophorectomy based on hereditary breast and ovarian cancer syndrome -associated gene mutations
Scientific Title:Acronym
A feasibility study of Risk-Reducing Salpingo-Oophorectomy based on hereditary breast and ovarian cancer syndrome -associated gene mutations
Region
| Japan |
Condition
Condition
Patients with mutations in BRCA1/2, BRIP, RAD51C and RAD51D genes
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate safety and long-term prognosis of RRSO
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long-term prognosis (incidence of peritoneal cancer, postoperative survival, cause of death, etc.)
Key secondary outcomes
a) Safety of the surgery (considerations associated with RRSO, etc.)
b) Onset of adverse events after surgery (other morbidity and mortality such as cardiovascular disease, artificial menopause, osteoporosis, unexpected complications, etc.)
c) Quality of life after surgery
d) Pathological examination of the removed bilateral ovaries, fallopian tubes (and uterus) (preparation of whole area histological sections)
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
| Medicine |
Interventions/Control_1
Risk Reducing Salpingo-Oophorectomy (RRSO)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Mutations have been identified in the BRCA1/2, BRIP, RAD51C and RAD51D genes, and the patient wishes to undergo RRSO.
(2) The patient should not have fertility problems and should already have a child. If the case of married woman, the patient's spouse's consent has been obtained. In the case of unmarried women, it is necessary that they have sufficient understanding of this matter.
(3) The patient should be able to understand the symptoms that may occur after RRSO surgery, especially the symptoms associated with artificial menopause.
(4) Patients should have received genetic counseling and have an understanding of the mutations in the BRCA1/2, BRIP, RAD51C, and RAD51D genes.
(5) The patient understands that, in principle, RRSO should be performed at his/her own expense except for complications of other diseases for which salpingo-oophorectomy is covered by insurance. However, patients with previous BRCA1/2 mutations who have an insurance indication for breast cancer will be treated with insurance.
(6) The patient understands the contents of this study and has given written consent.
Key exclusion criteria
(1) Patients who do not have sufficient judgment, are unconscious, or require consideration of the name of the disease
(2) Patients with serious life-threatening complications.
(3) Patients who are judged by the principal investigator to be inappropriate for inclusion in the study.
(4) Patients whose consent has not been obtained or who have requested to withdraw their consent.
(5) Any other patient whom the principal investigator or sub-investigator deems inappropriate to conduct this research.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto University School on Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Kawaharacho 54, Shogoin Sakyou-ku, Kyoto city
TEL
0757513269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University School on Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Kawaharacho 54, Shogoin Sakyou-ku, Kyoto city
TEL
0757513269
Homepage URL
soulken@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 22 | 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
| 2020 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2033 | Year | 01 | Month | 11 | 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 | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050964
