UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019970
Receipt number R000023059
Scientific Title Clinical investigation of liver perfusion CT as an imaging biomarker for gastrointestinal cancer
Date of disclosure of the study information 2015/12/01
Last modified on 2021/01/18 18:30:03

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Basic information

Public title

Clinical investigation of liver perfusion CT as an imaging biomarker for gastrointestinal cancer

Acronym

Perfusion CT for gastrointestinal cancer

Scientific Title

Clinical investigation of liver perfusion CT as an imaging biomarker for gastrointestinal cancer

Scientific Title:Acronym

Perfusion CT for gastrointestinal cancer

Region

Japan


Condition

Condition

Gastrointestinal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess correlation between cancer progression and hepatic blood flow as a imaging biomarker

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between postoperative hepatic blood flow and cancer relapse

Key secondary outcomes

Correlation between preoperative hepatic blood flow and cancer stage


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

Gastrointestinal cancer

Key exclusion criteria

Inadequate renal function

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Kiyohiko
Middle name
Last name Shuto

Organization

Teikyo University Chiba Medical Center

Division name

Surgery

Zip code

2990111

Address

3426-3 Anesaki, Ichihara, Chiba

TEL

0436-62-1211

Email

kshuto@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Kiyohiko
Middle name
Last name Shuto

Organization

Teikyo University Chiba Medican Center

Division name

Surgery

Zip code

29901111

Address

3426-3 Anesaki, Ichihara, Chiba

TEL

0436-62-1211

Homepage URL


Email

kshuto@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University Chiba Medical Center

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

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

Teikyo University Chiba Medical Center

Address

3426-3 Anesaki, Ichihara, Chiba

Tel

0436621211

Email

kshuto@med.teikyo-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 12 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

Enrolling by invitation

Date of protocol fixation

2013 Year 03 Month 18 Day

Date of IRB

2013 Year 03 Month 18 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2029 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Eligible patients who are admitted to our institution from 1 December, 2015.
Blood flow analysis.


Management information

Registered date

2015 Year 11 Month 28 Day

Last modified on

2021 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name