UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019710
Receipt number R000022763
Scientific Title A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium
Date of disclosure of the study information 2015/11/09
Last modified on 2019/11/12 14:31:06

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Basic information

Public title

A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium

Acronym

A retrospective study of neuroendocrine tumor of endometrium

Scientific Title

A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium

Scientific Title:Acronym

A retrospective study of neuroendocrine tumor of endometrium

Region

Japan


Condition

Condition

Neuroendocrine tumor of endometrium

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify treatment and prognosis of neuroendocrine tumor of endometrium, and to obtain findings to establish future individualized treatment.

Basic objectives2

Others

Basic objectives -Others

Retrospective observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

background factors, stage, tratments, pathological findings, prognosis

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients diagnosed with neuroendocrine tumor of endometrium between 1995 and 2014.

Key exclusion criteria

1) Patients with a history of chemotherapy and/or radiotherapy for other malignancy.
2) Patients with a severe complication.
3) Patients who have other malignancies.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Harunobu
Middle name
Last name Matsumoto

Organization

Faculty of Medicine, Oita University

Division name

Department of Obstetrics and Gynecology

Zip code

8795593

Address

1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan

TEL

097-586-5922

Email

matumoti@oita-u.ac.jp


Public contact

Name of contact person

1st name Harunobu
Middle name
Last name Matsumoto

Organization

Faculty of Medicine, Oita University

Division name

Department of Obstetrics and Gynecology

Zip code

8795593

Address

1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan

TEL

097-586-5922

Homepage URL


Email

matumoti@oita-u.ac.jp


Sponsor or person

Institute

Kansai Clinical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Kansai Clinical 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

Department of Obstetrics and Gynecology, Faculty of Medicine, Oita University

Address

1-1, Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan

Tel

097-586-5120

Email

syomu@oita-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

2015 Year 11 Month 09 Day


Related information

URL releasing protocol

http://www.med.oita-u.ac.jp/sanka/patient/index5.html

Publication of results

Published


Result

URL related to results and publications

https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103

Number of participants that the trial has enrolled

42

Results

Please refer to the link below.

https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103

Results date posted

2019 Year 05 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 07 Month 01 Day

Baseline Characteristics

Please refer to the link below.

https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103

Participant flow

Please refer to the link below.

https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103

Adverse events

Not applicable

Outcome measures

Please refer to the link below.

https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 07 Month 24 Day

Date of IRB

2015 Year 07 Month 24 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a multi-center retrospective study.


Management information

Registered date

2015 Year 11 Month 09 Day

Last modified on

2019 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022763


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name