UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001876 |
|---|---|
| Receipt number | R000002260 |
| Scientific Title | Japan endometrioma malignant transformation study |
| Date of disclosure of the study information | 2009/04/13 |
| Last modified on | 2018/04/19 10:46:21 |
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Basic information
Public title
Japan endometrioma malignant transformation study
Acronym
JEMS
Scientific Title
Japan endometrioma malignant transformation study
Scientific Title:Acronym
JEMS
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of the study are 1) to estimate the risk of malignant transformation of chocolate cyst accurately, 2) to detect risk factors of the ovarian cancer, and 3) to determine whether a cystectomy prevents the cancer, based on the nationwide cohort database that registers endometriosis patients with chocolate cyst over the ages of 30.
Basic objectives2
Others
Basic objectives -Others
Occurrence of ovarian cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of ovarian cancer
Key secondary outcomes
Episode of oophorectomy/ Incidence of breast cancer/ Incidence of Non-Hodgikin's lymphoma/ Incidence of thyroid cancer/ Episode of pregnancy and birth/ Mortality (all-cause death)
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
*Female patients who signed informed consent documents for the study.
*Patients who are pre-menopause, over the ages of 30.
*Patients who were diagnosed as endometriosis with chocolate cysts, according to MRI test or postoperative histopathological examination.
Key exclusion criteria
*Patients who were diagnosed as ovarian cancer according to diagnostic imaging at the first visit.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Terakawa |
Organization
Tottori University Faculty of Medicine
Division name
Division of Reproductive-Perinatal Medicine and Gynecologic Oncology
Zip code
Address
36-1 Nishi, Yonago, Tottori 683-8504 Japan
TEL
0859-33-1111
jems@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Hayashi |
Organization
Gunma University School of Health Science
Division name
Epidemiology and Biostatistics
Zip code
Address
3-39-15, Showa-machi, Maebashi, Gunma 371-8511 Japan
TEL
027-220-8974
Homepage URL
http://square.umin.ac.jp/JEMS/
khayashi@gunma-u.ac.jp
Sponsor or person
Institute
Japan Society of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (A) from the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japan Society of Obstetrics and Gynecology
Name of secondary funder(s)
Takeda Pharmaceutical Co., Ltd., Fuji Pharma Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nobelpharma Co., Ltd., Mochida Pharmaceutical Co., Ltd.
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
| 2009 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
http://square.umin.ac.jp/JEMS/
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study:
Occurrence of ovarian cancer
Management information
Registered date
| 2009 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002260
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
