UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042914 |
|---|---|
| Receipt number | R000048992 |
| Scientific Title | Clinical study of risk reducing salpingo-oophorectomy (RRSO) in patients with pathological variants of the BRCA1/2 gene |
| Date of disclosure of the study information | 2021/01/06 |
| Last modified on | 2021/01/05 19:09:25 |
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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
| Obstetrics 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
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
mariya.tasuku@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical 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
Clinical trial center, Sapporo Medical University
Address
South 1 West 16, Chuo-ku, Sapporo 060-8543
Tel
0116112111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048992
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| Registered date | File name |
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