UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012128
Receipt number R000014142
Scientific Title Computed tomographic colonography versus colon capsule endoscopy for investigation of patients with symptoms suggestive of colorectal tumor
Date of disclosure of the study information 2013/11/16
Last modified on 2018/02/01 09:57:43

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Basic information

Public title

Computed tomographic colonography versus colon capsule endoscopy for investigation of patients with symptoms suggestive of colorectal tumor

Acronym

CTC versus CTE for investigation of colorectal tumor

Scientific Title

Computed tomographic colonography versus colon capsule endoscopy for investigation of patients with symptoms suggestive of colorectal tumor

Scientific Title:Acronym

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

1st name
Middle name
Last name Ken Haruma

Organization

Kawasaki Medical School and Hospital

Division name

Gastroenterology

Zip code


Address

577 Matsushima, Kurashiki city, Okayama, JAPAN

TEL

086-462-1111

Email

hmatsumoto0311@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Matsumoto

Organization

Kawasaki Medical School and Hospital

Division name

Gastroenterology

Zip code


Address

577 Matsushima, Kurashiki city, Okayama, JAPAN

TEL

086-462-1111

Homepage URL


Email

hmatsumoto0311@gmail.com


Sponsor or person

Institute

Kawasaki Medical School and Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Terminated

Date of protocol fixation

2013 Year 11 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014142


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name