UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036755 |
|---|---|
| Receipt number | R000041885 |
| Scientific Title | Study of New Prognostic Factors in Patients Who Received Postoperative Chemotherapy for Endometrial Cancer(JGOG2043-A2) |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2025/05/18 16:03:21 |
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Basic information
Public title
Study of New Prognostic Factors in Patients Who Received Postoperative Chemotherapy for Endometrial Cancer(JGOG2043-A2)
Acronym
JGOG2043-A2
Scientific Title
Study of New Prognostic Factors in Patients Who Received Postoperative Chemotherapy for Endometrial Cancer(JGOG2043-A2)
Scientific Title:Acronym
JGOG2043-A2
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study group comprised 781 patients who were enrolled in the JGOG2043 trial and received chemotherapy
Basic objectives2
Others
Basic objectives -Others
Retrospective subset analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We analyzed new prognostic factors in patients who received postoperative chemotherapy for endometrial cancer (patients enrolled in the JGOG2043 study) to investigate an effective classification for clinical practice and new stratification factors for clinical studies.
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
The study group comprised 781 patients who were enrolled in the JGOG2043 trial and received chemotherapy.
Key exclusion criteria
None
Target sample size
781
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Nishio |
Organization
Japanese Gynecologic Oncology Group
Division name
Endometrial cancer committee
Zip code
162-0825
Address
6-22 Kagurazaka, Shinjuku, Tokyo
TEL
03-5206-1982
info@jgog.gr.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Nishio |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942-31-7573
Homepage URL
shinshin@med.kurume-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume Univeristy
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942-35-3311
i_rinri@kurume-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
| 2019 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://jgog.gr.jp/kaiin/kaiin2/enforcement_outline/jgog2043A2/JGOG2043-A2.html
Publication of results
Published
Result
URL related to results and publications
https://www.gynecologiconcology-online.net/article/S0090-8258(23)01604-9/abstract
Number of participants that the trial has enrolled
712
Results
Pretreatment systemic inflammatory markers are associated with survival outcomes in patients with endometrial cancer, with the HALP score being a prognostic factor for PFS and OS.
Results date posted
| 2025 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
712 Japanese endometrial cancer patients
Participant flow
Data from the Japanese Gynecologic Oncology Group 2043 were analyzed.
Adverse events
n/a
Outcome measures
For PFS, optimal NLR, PLR, and HALP score cutoff values were 1.48, 0.017, and 35.52, respectively, and for OS, the values were 1.88, 0.026, and 19.87, respectively. At optimal PFS-related cutoff values, NLR was associated with BMI; PLR with age, BMI, and clinical stage; and HALP score with BMI, clinical stage, and lymph node metastasis. At optimal OS-related cutoff values, NLR was associated with BMI, PLR, and BMI; the HALP score was associated with age and BMI. The HALP score was a prognostic factor for PFS (p = 0.025), while PLR and HALP scores were prognostic factors for OS (both p = 0.028).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Retrospective subset analysis
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041885
