UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029515 |
|---|---|
| Receipt number | R000033726 |
| Scientific Title | risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2023/10/15 14:37:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Acronym
risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Scientific Title
risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Scientific Title:Acronym
risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Region
| Japan |
Condition
Condition
Unaffected pathogenic variant carriers of hereditary gynecologic tumors
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
in preparation
Basic objectives2
Others
Basic objectives -Others
in preparation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
in preparation
Key secondary outcomes
in preparation
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
| Gene | Maneuver |
Interventions/Control_1
risk-reducing surgery
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
| Not applicable |
Gender
Female
Key inclusion criteria
in preparation
Key exclusion criteria
No
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
kobax@a2.keio.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
Homepage URL
kobax@a2.keio.jp
Sponsor or person
Institute
Department of Obstetrics & Gynecology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2017 | Year | 10 | Month | 11 | 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
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2037 | 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
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
