UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035942
Receipt number R000040879
Scientific Title Examination of body composition change of patients with esophageal cancer
Date of disclosure of the study information 2019/02/20
Last modified on 2022/08/23 13:39:17

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Basic information

Public title

Examination of body composition change of patients with esophageal cancer

Acronym

Esophageal cancer and body composition change

Scientific Title

Examination of body composition change of patients with esophageal cancer

Scientific Title:Acronym

Esophageal cancer and body composition change

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective is to examine body composition change of patients with esophageal cancer- comparison before and after endoscopic submucosal dissection.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome is body composition change of patients with esophageal cancer- comparison before and after endoscopic submucosal dissection.

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with esophageal cancer

Key exclusion criteria

1) Patients having another severe disorders
2) Patients who can not open the mouth widely
3) Patients who are judged by the investigators to be inappropriate participants in the study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shuji
Middle name
Last name Terai

Organization

Graduate School of Medical and Dental Sciences, Niigata University

Division name

Division of Gastroenterology and Hepatology

Zip code

951-8510

Address

1-757, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan

TEL

025-227-2207

Email

terais@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Mizusawa

Organization

Graduate School of Medical and Dental Sciences, Niigata University

Division name

Division of Gastroenterology and Hepatology

Zip code

951-8510

Address

1-757, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan

TEL

025-227-2207

Homepage URL


Email

tmizu@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

N/A

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

Graduate School of Medical and Dental Sciences, Niigata University

Address

1-757, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan

Tel

025-227-2207

Email

tmizu@med.niigata-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 02 Month 20 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

Completed

Date of protocol fixation

2018 Year 07 Month 20 Day

Date of IRB

2018 Year 07 Month 11 Day

Anticipated trial start date

2018 Year 07 Month 20 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational research


Management information

Registered date

2019 Year 02 Month 19 Day

Last modified on

2022 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name