UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011153 |
|---|---|
| Receipt number | R000013059 |
| Scientific Title | A retrospective study of malignant transformation of ovarian teratoma(KCOG-G1305s) |
| Date of disclosure of the study information | 2013/07/09 |
| Last modified on | 2015/09/02 11:02:39 |
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Basic information
Public title
A retrospective study of malignant transformation of ovarian teratoma(KCOG-G1305s)
Acronym
KCOG-G1305s
Scientific Title
A retrospective study of malignant transformation of ovarian teratoma(KCOG-G1305s)
Scientific Title:Acronym
KCOG-G1305s
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the currnet treatment and clinicopathologic factors affecting survival of malignant transformation arising in ovarian mature cystic teratoma retrospectively. Secondary to get some perceptions to establish standard of care against the tumor.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study for rare tumor
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A method of Treatments
Key secondary outcomes
Prognostic factors
Base
Study type
Observational
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
The cases of malignant transformation of ovarian mature cystic teratoma treated from November 1998 to December 2012,with 1a to 4b by FIGO stage
Key exclusion criteria
1.Patients with a history of other malignancies. The patients with recurrence free for more than 5 years are eligible. 2.Patients with serious complications. 3.Patients with the other malignant disease requiring treatment at a time.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Sugiura |
Organization
Nara prefecture general medical center
Division name
Obstetrics and gynecology
Zip code
Address
1-30-1, Hiramatsu Nara city, Nara prefecture
TEL
0742-46-6001
atsushi7707@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sugiura |
Organization
Nara prefecture general medical center
Division name
Obstetrics and gynecology
Zip code
Address
1-30-1, Hiramatsu Nara city, Nara prefecture
TEL
0742-46-6001
Homepage URL
atsushi7707@yahoo.co.jp
Sponsor or person
Institute
Kansai clinical oncology group
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
KCOG-G1305s
Org. issuing International ID_1
Kansai clinical oncology group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
This study aims to investigate the currnet treatment and clinicopathologic factors affecting survival of malignant transformation arising in ovarian mature cystic teratoma retrospectively. Secondary to get some perceptions to establish standard of care against the tumor.
Management information
Registered date
| 2013 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
