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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001876
Receipt No. R000002260
Scientific Title Japan endometrioma malignant transformation study
Date of disclosure of the study information 2009/04/13
Last modified on 2018/04/19

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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
Obsterics 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
Email 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/
Email khayashi@gunma-u.ac.jp

Sponsor
Institute Japan Society of Obstetrics and Gynecology
Institute
Department

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
Email

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
URL(English) https://upload.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


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