UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan endometrioma malignant transformation study
Title of the study (Brief title)	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	Naoki Terakawa
Organization	Tottori University Faculty of Medicine
Division name	Division of Reproductive-Perinatal Medicine and Gynecologic Oncology
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	Kunihiko Hayashi
Organization	Gunma University School of Health Science
Division name	Epidemiology and Biostatistics
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.

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 08 Month 23 Day
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

Related information
URL releasing protocol	http://square.umin.ac.jp/JEMS/
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002260