UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034159
Receipt No. R000038925
Scientific Title 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
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Gynecological investigation for the teratoma-associated anti-NMDAR encephalitis
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Hironori Tashiro
Organization Kumamoto University
Division name Faculty of Life Sciences
Zip code
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
1st name
Middle name
Last name Iso Sakaguchi
Organization Kumamoto University Hospital
Division name Obstetrics and Gynecology
Zip code
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)

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
2018 Year 09 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.