UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034159 |
|---|---|
| Receipt number | 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 15:05:20 |
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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
| Obstetrics 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
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
isakakuh@gmail.com
Sponsor or person
Institute
Japan Society of Obstetrics and Gynecology
Committee on Gynecologic Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038925
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