UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037500
Receipt No. R000042742
Scientific Title Perioperative change of body composition in patients with cancer: a prospective observational study
Date of disclosure of the study information 2019/08/01
Last modified on 2020/07/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Perioperative change of body composition in patients with cancer: a prospective observational study
Acronym Perioperative change of body composition in patients with cancer
Scientific Title Perioperative change of body composition in patients with cancer: a prospective observational study
Scientific Title:Acronym Perioperative change of body composition in patients with cancer
Region
Japan

Condition
Condition Gastroenterological cancer
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate perioperative change of body composition in patients with gastroenterological cancer undergoing elective surgery
Basic objectives2 Others
Basic objectives -Others To investigate perioperative change of body composition and nutritional parameters from preoperative period to 12months after the operation in patients with gastroenterological cancer undergoing elective surgery
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Change of skeletal muscle mass 12 months after the operation
Key secondary outcomes (1) Change of body composition
(2) Association between change of skeletal muscle mass and clinicopathological factors
(3) Change of nutritional parameters
(4) Adverse events

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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Gastroenterological cancer confirmed by histological examination or images
(2) Age of 20 years or older
(3) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
(4) Written informed consent
Key exclusion criteria (1) Patients with other cancers
(2) Severe heart disease and heart failure
(3) Severe respiratory disease
(4) Pregnancy or insufficient contraception
(5) Mental disorder
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Migita
Organization Nara Prefecture Seiwa Medical Center
Division name Surgery
Zip code 636-0802
Address 1-14-16 Mimuro Sango-cho Ikoma
TEL 0745-32-0505
Email kmigita@naramed-u.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Migita
Organization Nara Prefecture Seiwa Medical Center
Division name Surgery
Zip code 636-0802
Address 1-14-16 Mimuro Sango-cho Ikoma
TEL 0745-32-0505
Homepage URL
Email kmigita@naramed-u.ac.jp

Sponsor
Institute Nara Prefecture Seiwa Medical Center
Institute
Department

Funding Source
Organization Nara Prefecture Seiwa Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee on Clinical Investigation of Nara Prefecture Seiwa Medical Center
Address 1-14-16 Mimuro Sango-cho Ikoma
Tel 0745-32-0505
Email seiwa@nara-pho.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 奈良県西和医療センター

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 23 Day
Date of IRB
2019 Year 07 Month 23 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
2022 Year 01 Month 31 Day
Date trial data considered complete
2022 Year 01 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information None

Management information
Registered date
2019 Year 07 Month 26 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.