UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of Micro-Computed Tomography in Gastroenterologic Diseases
Title of the study (Brief title)	Feasibility study of Micro-Computed Tomography in Gastroenterologic Diseases
Region	Japan

Condition
Condition	tumors of gastrointestinal tract
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to clarify the usefullness of Micro-Computed Tomography in Gastroenterologic Diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability of Micro-Computed Tomography on invasion depth of tumors of gastrointestinal tract
Key secondary outcomes	Diagnostic ability of Micro-Computed Tomography on delineation of the layer structures of the gastrointestinal tract Diagnostic ability of Micro-Computed Tomography on degree of tumor differentiation

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 days-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have a therapy for tumors of the gastrointestinal tract
Key exclusion criteria	Patients whom a resercher judged to be inappropriate as a subject
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshiki Hirooka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Endoscopy
Address	65,Tsuruma-cho Showa-ku,Nagoya,466-855 Japan
TEL	052-744-2431
Email	komiyama@med.nagoya-u.ac.jp

Public contact
Name of contact person	Takuma Komiyama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65,Tsuruma-cho Showa-ku,Nagoya,466-855 Japan
TEL	052-744-2431
Homepage URL
Email	komiyama@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine,department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine,department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Clinical observation study

Management information
Registered date	2017 Year 06 Month 13 Day
Last modified on	2018 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030264