UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Computed tomographic colonography versus colon capsule endoscopy for investigation of patients with symptoms suggestive of colorectal tumor
Title of the study (Brief title)	CTC versus CTE for investigation of colorectal tumor
Region	Japan

Condition
Condition	colorectal tumor
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study is to evaluation of accuuracy of both CT colonography and colon capsule endoscopy against colorectal tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of detection ability of CTC and CCE
Key secondary outcomes	The dofference of ability of CCE by preexamination treatments, Adherence of patient with CCE Frequncy of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	CTC vs CTE
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	1. Patients who would be have colorectal disease. 2. Signed informed consent forms are obtained by the patients
Key exclusion criteria	1.Patients who be with serious medical condition by any disease 2.Subjects whose eligibility for this trial is not appropriate by other reasons 3.Patients who have intestinal stenosis, obstraction 4.Patients who have deep colonic ulcers including toxic megacolon
Target sample size	100

Research contact person
Name of lead principal investigator	Ken Haruma
Organization	Kawasaki Medical School and Hospital
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama, JAPAN
TEL	086-462-1111
Email	hmatsumoto0311@gmail.com

Public contact
Name of contact person	Hiroshi Matsumoto
Organization	Kawasaki Medical School and Hospital
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama, JAPAN
TEL	086-462-1111
Homepage URL
Email	hmatsumoto0311@gmail.com

Sponsor
Institute	Kawasaki Medical School and Hospital
Institute
Department

Funding Source
Organization	None
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	川崎医科大学附属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 11 Month 16 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
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

Management information
Registered date	2013 Year 10 Month 26 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014142