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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042914
Receipt No. 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

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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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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