UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032056 |
|---|---|
| Receipt number | R000036570 |
| Scientific Title | Risk Reduction Surgery for Hereditary Breast and Ovarian Cancer Syndrome in Tsukuba |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2018/04/02 11:32:18 |
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Basic information
Public title
Risk Reduction Surgery for Hereditary Breast and Ovarian Cancer Syndrome in Tsukuba
Acronym
Risk Reduction Surgery for HBOC Syndrome in Tsukuba
Scientific Title
Risk Reduction Surgery for Hereditary Breast and Ovarian Cancer Syndrome in Tsukuba
Scientific Title:Acronym
Risk Reduction Surgery for HBOC Syndrome in Tsukuba
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer Sundrome
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore safety and efficacy of risk reduction surgery for HBOC syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of occult breast cancer for risk reduction mastectomy.
Incidence of occult cancer, STIC, and positive cancer cells by cytodiagnosis of ascites.
Key secondary outcomes
Safety of surgery, duration of hospital stay, incidence of breast and peritoneal cancer after risk reduction surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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: Mastectomy and/or salpingo-oophorectomy
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
Case diagnosed as Hereditary breast and ovarian cancer syndrome.
Case with breast and/or ovarian cancer history must have undergone curative treatment and should be cancer free at inclusion.
Key exclusion criteria
Case who do not want to participate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Bando |
Organization
University of Tsukuba Hospital
Division name
Breast and Endocrine Surgery
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3341
bando@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Bando |
Organization
University of Tsukuba Hospital
Division name
Breast and Endocrine Surgery
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3341
Homepage URL
bando@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Address
Tel
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 | 04 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036570
