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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036755
Receipt No. 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 2019/05/15

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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
Obsterics 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
Email 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
Email shinshin@med.kurume-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

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
Email 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
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 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
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective subset analysis

Management information
Registered date
2019 Year 05 Month 15 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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