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 2021/12/04 23:23:38

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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

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 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

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

718

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

No longer recruiting

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

2021 Year 12 Month 04 Day



Link to view the page

Value
https://center6.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