UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020716 |
|---|---|
| Receipt number | R000023902 |
| Scientific Title | Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2024/10/07 05:53:15 |
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Basic information
Public title
Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients
Acronym
RRSO QOL Study
Scientific Title
Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients
Scientific Title:Acronym
RRSO QOL Study
Region
| Japan |
Condition
Condition
Hereditary breast ovarian cancer syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigating the QOL changes in the HBOC patients before and after RRSO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of QOL
Key secondary outcomes
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
| Other |
Interventions/Control_1
Questionnaire
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
Over 20 year old, hope for RRSO, germline BRCA1/2 mutation(+)
Key exclusion criteria
no criteria
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | ryutaro |
| Middle name | |
| Last name | Nishikawa |
Organization
Nagoya city east medical center
Division name
Gynecology
Zip code
4648547
Address
1-2-23 Wakamizu, Chikusa-Ku, Nagoya-City
TEL
052-721-7171
ryu0717@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | ryutaro |
| Middle name | |
| Last name | Nishikawa |
Organization
Nagoya city east medical center
Division name
Gynecology
Zip code
4648547
Address
1-2-23 Wakamizu, Chikusa-Ku, Nagoya-City
TEL
052-721-7171
Homepage URL
ryu0717@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya city east medical center
Institute
Department
Personal name
Funding Source
Organization
Patient
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya city east medical center
Address
1-2-23 Wakamizu, Chikusa-Ku, Nagoya-City
Tel
052-721-7171
ryu0717@med.nagoya-cu.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
| 2016 | Year | 01 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 28 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
QOL
Management information
Registered date
| 2016 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023902
