UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for the relation between the timing and method of operation for ovarian teratoma and the short-term outcome of teratoma-associated anti-NMDA receptor encephalitis
Title of the study (Brief title)	Gynecological investigation for the teratoma-associated anti-NMDAR encephalitis
Region	Japan

Condition
Condition	Ovarian teratoma-associated anti-NMDA receptor encephalitis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Anti-N-methyl-D-aspartate (NMDA)-receptor (R) encephalitis was initially described by Dalmau and colleagues in 2007 when they discovered the anti-NMDAR antibody in a set of young females who had an array of neurological symptoms in association with ovarian teratomas. The typical clinical picture presents with neuropsychiatric symptoms, seizures, dyskinesias, autonomic dysregulation, and dyspnea. The association of ovarian teratoma and anti-NMDAR encephalitis is a serious and potentially fatal disorder that occurs in young women and is thought to be paraneoplastic, in particular due to the rapid clinical improvement after the treatment for the teratoma. However, operative methods (open laparotomy or laparoscopic surgery / cystectomy or ovariectomy) for ovarian teratomas are not uniform in Japan. Objectives are to analyze prevalence and outcome of this association, and increase awareness over this disorder. This study will investigate the timing of operation, surgery method (open laparotomy or laparoscopic surgery / ovarian cystectomy or oophorectomy) for ovarian teratoma in young patients with this encephalitis, and the short-term outcome of the related symptoms after the operation, and will provide practical guidance of the rare disorder for the general gynecologist.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Short-term outcome (improved symptoms) by each operative method for the ovarian teratoma
Key secondary outcomes

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	10 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	1. anti-NMDA receptor encephalitis 2. with ovarian teratoma 3. positive antibody for anti-NMDA receptor
Key exclusion criteria	1. paraneoplastic limbic encephalitis excepting anti-NMDA receptor encephalitis 2. without ovarian teratoma 3. negative for anti-NMDA receptor
Target sample size	100

Research contact person
Name of lead principal investigator	Hironori Tashiro
Organization	Kumamoto University
Division name	Faculty of Life Sciences
Address	4-24-1 Kuhonji, Chuo-ku, Kumamoto city, 860-0976 JAPAN
TEL	096-373-5269
Email	htashiro@kumamoto-u.ac.jp

Public contact
Name of contact person	Iso Sakaguchi
Organization	Kumamoto University Hospital
Division name	Obstetrics and Gynecology
Address	1-1-1 Honjo, Chuo-Ku, Kumamoto city, 860-8556
TEL	096-373-5269
Homepage URL	https://www.e-igakukai.jp/user_service/kaiin_portal/ml_ap/ml_login.htm
Email	isakakuh@gmail.com

Sponsor
Institute	Japan Society of Obstetrics and Gynecology Committee on Gynecologic Oncology
Institute
Department

Funding Source
Organization	Japan Society of Obstetrics and Gynecology Committee on Gynecologic Oncology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 09 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 13 Day
Anticipated trial start date	2018 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observational research

Management information
Registered date	2018 Year 09 Month 15 Day
Last modified on	2018 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038925