UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055120 |
|---|---|
| Receipt number | R000062969 |
| Scientific Title | Transfationa research of observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy |
| Date of disclosure of the study information | 2024/08/08 |
| Last modified on | 2024/07/30 20:16:09 |
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Basic information
Public title
Transfationa research of observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy
Acronym
JGOG2055s-TR1
Scientific Title
Transfationa research of observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy
Scientific Title:Acronym
JGOG2055s-TR1
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the molecular subtype classification of advanced and recurrent endometrial cancer in Japan, targeting advanced and recurrent endometrial cancer cases enrolled in JGOG2055s/PEACH study.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness and safety of treatment after progression/relapse based on molecular subtype classification, and to search for biomarkers in JGOG2055s/PEACH study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of four classifications using molecular genetic classification
Key secondary outcomes
Progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) of each treatment by molecular genetic classification
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Advanced or recurrent endometrial cancer (including carcinosarcoma) registered in JGOG2055s/PEACH study
2. Patients who have not withdrawn their consent during their participation in the PEACH study and who have provided written consent to participate in this study.
3. Patients who can provide sufficient amount of tumor tissue
4. Patients who can consider donating blood or normal tissue specimens within the research subject registration period (one year from the date of permission from the head of the research institution)
5. When the principal investigator or research office determines that it is appropriate for the case to be registered in the study.
Key exclusion criteria
1. If the period from the acquisition of tumor tissue and blood samples to the date of registration for this study (date of consent obtained) exceeds 5 years, or if it is difficult to provide a sufficient amount of tissue.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junzo |
| Middle name | |
| Last name | Hamanishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin Kawaharacho Sakyo Kyoto
TEL
0757513269
jnkhmns@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Takahashi |
Organization
JGOG
Division name
JGOG office
Zip code
162-0825
Address
4th floor Komatsu building 6-22Kagurazaka Shinjuku, Tokyo
TEL
03-5206-1982
Homepage URL
info@jgog.gr.jp
Sponsor or person
Institute
JGOG
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As this study is an observational study, the treatments given are within the standard of care and are not expected to provide any direct benefit to the participants. However, this study is expected to contribute significantly to the effective and safe drug therapy for uterine corpus cancer in actual clinical practice in our country, which could benefit future patients with uterine corpus cancer. Therefore, the study is considered to have a high social contribution.
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062969
