UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011360 |
|---|---|
| Receipt number | R000013199 |
| Scientific Title | Assessment of incidence and persevation of malignant transformation for endometriosis in Japan |
| Date of disclosure of the study information | 2013/08/04 |
| Last modified on | 2014/05/07 10:02:52 |
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Basic information
Public title
Assessment of incidence and persevation of malignant transformation for endometriosis in Japan
Acronym
Assessment of malignant transformation of endometriosis
Scientific Title
Assessment of incidence and persevation of malignant transformation for endometriosis in Japan
Scientific Title:Acronym
Assessment of malignant transformation of endometriosis
Region
| Japan |
Condition
Condition
Endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of study is to assess incidence of malignant alteration of endometriosis and whether medical management can prevent the alterration or not
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of malignant alteration
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) woman who had regular menstruation and whose age is more than 30 years old.
2) patients who was diagnosed ovarian endometrioma by pelvic MRI or postoperative histopathologic analysis.
Key exclusion criteria
Patients who had ovarian malignancies
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
kumakiri@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 08 | Month | 04 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We send our data to the registration center located in Tottori University for data analysis.
Management information
Registered date
| 2013 | Year | 08 | Month | 03 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013199
| 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 |
