UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052365 |
|---|---|
| Receipt number | R000059773 |
| Scientific Title | JGOG-ToMMo Biobank Project |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/10/01 10:33:21 |
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Basic information
Public title
JGOG-ToMMo Biobank Project
Acronym
JGOG-ToMMo Biobank Project
Scientific Title
JGOG-ToMMo Biobank Project
Scientific Title:Acronym
JGOG-ToMMo Biobank Project
Region
| Japan |
Condition
Condition
Gynecologic malignant disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
For research subjects enrolled in clinical trials conducted by the Japan Gynecologic Malignancy Research Organization (JGOG), biospecimens collected during medical treatment will be stored at the Tohoku Medical Megabank Organization (ToMMo), regardless of whether a sample analysis study has been planned in advance. The stored biospecimens will be used for integrated analysis of medical information and various analyses, including genetic analysis, based on a future sample analysis research plan that has been submitted to and approved by the Ethics Committee. Thus, the purpose of this study is to make secondary use of biospecimens and medical information from research subjects enrolled in clinical trials in future bridging research.
Basic objectives2
Others
Basic objectives -Others
Banking of biological specimens
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
No key outcomes will be established for the banking business.
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
-Subjects who have enrolled in JGOG clinical trials
-Subjects who have provided written consent for the donation of biospecimens to this Biobank Project and for the secondary use of medical information and biospecimens obtained in clinical trials for future translational research
Key exclusion criteria
Subjects who do not agree to provide biological samples and medical information to this biobank project
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Aikou |
| Middle name | |
| Last name | Okamoto |
Organization
Specified non-profit corporation, Japanese Gynecologic Oncology Group
Division name
President
Zip code
162-0825
Address
Komatsu Building 4F, 6-22 Kagurazaka, Shinjuku-ku, Tokyo, Japan
TEL
03-5206-1982
info@jgog.gr.jp
Public contact
Name of contact person
| 1st name | Muneaki |
| Middle name | |
| Last name | Shimada |
Organization
Tohoku University
Division name
Advanced Research Center for Innovations in Next-Generation Medicine
Zip code
980-8573
Address
3F, Tohoku Medical Megabank Building, 2-1 Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL
022-274-2371
Homepage URL
https://jgog.gr.jp
muneaki.shimada.b7@tohoku.ac.jp
Sponsor or person
Institute
Specified non-profit corporation, 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
The Tohoku University Tohoku Medical Megabank Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi, 980-8574 Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
1.東北大学大学院医学系研究科（宮城県）/ Tohoku University Graduate School of Medicine (Miyagi Prefecture)
2.自治医科大学（栃木県）/ Jichi Medical University (Tochigi Prefecture)
3.久留米大学病院（福岡県）/ Kurume University Hospital (Fukuoka Prefecture)
4.兵庫県立がんセンター（兵庫県）/ Hyogo Cancer Center (Hyogo Prefecture)
5.日本医科大学付属病院（東京都）/ Nippon Medical School Hospital (Tokyo)
6.弘前大学大学院医学研究科（青森県）/ Hirosaki University Graduate School of Medicine (Aomori Prefecture)
7.名古屋大学医学部附属病院（愛知県）/ Nagoya University Hospital (Aichi Prefecture)
8.慶応義塾大学病院（東京都）/ Keio University Hospital (Tokyo)
9.北海道大学病院（北海道）/ Hokkaido University Hospital (Hokkaido)
10.近畿大学医学部（大阪府）/ KINDAI University School of Medicine (Osaka Prefecture)
11.岡山大学（岡山県）/ Okayama University (Okayama Prefecture)
12.東京慈恵会医科大学附属病院（東京都）/ The Jikei University Hospital (Tokyo)
13.東京慈恵会医科大学附属柏病院（千葉県）/ The Jikei University Kashiwa Hospital (Chiba Prefecture)
14.東京慈恵会医科大学附属第三病院（東京都）/ The Jikei University Daisan Hospital (Tokyo)
15.東京慈恵会医科大学葛飾医療センター（東京都）/ The Jikei University Katsushika Medical Center (Tokyo)
16.東京大学医学部附属病院（東京都）/The University of Tokyo Hospital(Tokyo)
17.四国がんセンター（愛媛県）/NHO Shikoku Cancer Center(Ehime Prefecture)
18.新潟大学医歯学総合病院（新潟県）/Niigata University Medical & Dental Hospital(Niigata Prefecture)
19.静岡がんセンター（静岡県）/Shizuoka Cancer Center(Shizuoka Prefecture)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For research subjects enrolled in clinical trials conducted by the Japan Gynecologic Malignancy Research Organization (JGOG), biospecimens collected during medical treatment will be stored at the Tohoku Medical Megabank Organization (ToMMo), regardless of whether a sample analysis study has been planned in advance. The stored biospecimens will be used for integrated analysis of medical information and various analyses, including genetic analysis, based on a future sample analysis research plan that has been submitted to and approved by the Ethics Committee. Thus, the purpose of this study is to make secondary use of biospecimens and medical information from research subjects enrolled in clinical trials in future bridging research.
Management information
Registered date
| 2023 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059773
