UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054168 |
|---|---|
| Receipt number | R000061847 |
| Scientific Title | A nationwide retrospective study of malignant tumors arising from ovarian mature teratoma in Japan |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2024/10/16 18:28:48 |
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Basic information
Public title
A nationwide retrospective study of malignant tumors arising from ovarian mature teratoma in Japan
Acronym
JGOG3034
Scientific Title
A nationwide retrospective study of malignant tumors arising from ovarian mature teratoma in Japan
Scientific Title:Acronym
JGOG3034
Region
| Japan |
Condition
Condition
malignant tumors arising from ovarian mature teratoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm the current status of ovarian cancer originating from ovarian mature teratoma in Japan, we will investigate the clinical backgrounds of patients, tumor characteristics, treatment details, and prognosis.
It will also serve as a historical cohort for comparing the therapeutic efficacy of pembrolizumab therapy in the ongoing JGOG 3029 trial. Additionally, this information will be valuable in designing future prospective clinical trials focusing on ovarian cancer arising from ovarian mature teratoma.
Basic objectives2
Others
Basic objectives -Others
Survey of rare cancer
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
No key outcomes will be established.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cases with a confirmed histological diagnosis of malignancy arising from ovarian mature teratoma during the 10-year period from July 2013 to June 2023.
Key exclusion criteria
The individual or family member has clearly expressed a refusal to opt out. The researcher considers it inappropriate, citing difficulties in obtaining data.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tamura |
Organization
Niigata University
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata, Japan
TEL
025-227-2320
ryo-h19@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tamura |
Organization
Niigata University
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata, Japan
TEL
025-227-2320
Homepage URL
http://jgog.gr.jp/
ryo-h19@med.niigata-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Specified non-profit corporation, Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Niigata University
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
新潟大学（新潟県）、東北大学病院（宮城県）、自治医科大学（栃木県）、四国がんセンター（愛媛県）、愛媛大学（愛媛県）、公益財団法人田附興風会 医学研究所北野病院（大阪府）、産業医科大学（福岡県）、熊本大学病院（熊本県）、茨城県立中央病院（茨城県）、久留米大学（大分県）、愛知がんセンター（愛知県）、信州大学医学部附属病院（長野県）、東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、東京慈恵会医科大学葛飾医療センター（東京都）、東京慈恵会医科大学附属第三病院（東京都）、静岡県立静岡がんセンター（静岡県）、山口大学医学部附属病院（山口県）、大阪大学医学部附属病院（大阪府）、兵庫県立がんセンター（兵庫県）、東京医科大学（東京都）、北海道大学（北海道）、東京大学医学部附属病院 (東京都)、国家公務員共済組合連合会 虎の門病院 (東京都)、神戸市立医療センター中央市民病院 (兵庫県）、名古屋大学医学部附属病院 (愛知県)、自治医科大学附属さいたま医療センター(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical backgrounds of patients, tumor characteristics, treatment details, and prognosis of ovarian cancer arisingfrom ovarian mature teratoma in Japan.
Management information
Registered date
| 2024 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061847
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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