UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015624 |
|---|---|
| Receipt number | R000018154 |
| Scientific Title | Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan: A Retrospective Analysis |
| Date of disclosure of the study information | 2014/11/06 |
| Last modified on | 2018/05/11 15:33:42 |
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Basic information
Public title
Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan:
A Retrospective Analysis
Acronym
Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan
Scientific Title
Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan:
A Retrospective Analysis
Scientific Title:Acronym
Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan
Region
| Japan |
Condition
Condition
Mullerian Epithelial Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of overall survival after secondary debulking surgery.
Basic objectives2
Others
Basic objectives -Others
To investigate current status of recurrence after secondary debulking surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cases which became complete response between January, 2000 to September, 2014. And the cases recurrenced.
Key exclusion criteria
Cases which they did not became complete response after recurrence.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Hirakawa |
Organization
Oita University, Oita, Japan
Division name
Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address
Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita 879-5593, Japan
TEL
097-586-5922
tomokoh@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Hirakawa |
Organization
Oita University, Oita, Japan
Division name
Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address
Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita 879-5593, Japan
TEL
097-586-5922
Homepage URL
tomokoh@oita-u.ac.jp
Sponsor or person
Institute
KCOG
Institute
Department
Personal name
Funding Source
Organization
KCOG
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
YES
Study ID_1
KCOG-G1402
Org. issuing International ID_1
KCOG-G1402
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Not yet
Management information
Registered date
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018154
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/11/08 | KCOG-G1402プロトコール2015年04月.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/11/08 | KCOG-G1402プロトコール2015年04月.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/11/08 | Fig 2.pptx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/18154
