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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012747
Receipt No. R000014897
Scientific Title Open-label randomizsed comparative study of the detection rates of colorectal tumors/polyps between colon capsule endoscopy and CT colonography
Date of disclosure of the study information 2014/01/03
Last modified on 2014/07/03

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Basic information
Public title Open-label randomizsed comparative study of the detection rates of colorectal tumors/polyps between colon capsule endoscopy and CT colonography
Acronym COLOCAT study
Scientific Title Open-label randomizsed comparative study of the detection rates of colorectal tumors/polyps between colon capsule endoscopy and CT colonography
Scientific Title:Acronym COLOCAT study
Region
Japan

Condition
Condition Colorectal tumors/polyps
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 CT colonography has not only been reimbursed since August, 2012, but also colon capsule endoscopy is going to be reimbursed since January, 2014 in Japan. The aim of this study is to determine the usefulness and safety of these two examinations to screen for colorectal tumors/polyps by a randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Sensitivity and specificity of colon capsule and CT colonography for colorectal tumors/polyps
Key secondary outcomes Adverse events, examination time, compliance, and detection rates of colorectal tumors or polyps stratified by fetal hemoglobin concentration.

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 colon capsule endoscopy
Interventions/Control_2 CT colonography
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 Patients with positive fecal immunological tests or symptoms suspicious of harboring colorectal tumors or polyps
Key exclusion criteria 1. Patients with dysphasia
2. Patients with drug allergy used in this study.
3. Pregnant or possible pregnant women
4. Patients who will undergo MRI 2weeks after colon capsule endoscopy
5. Patients with present or past history of small and large bowel obstruction
6. Patients suspicious of having colorectal advanced carcinoma by tumor markers or symptoms
7. Patients inappropriate for this study by other reasons judged by investigators
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kato, Hiramatsu
Organization Fujita Health University School of Medicine
Division name IRB
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-2139
Homepage URL
Email chiken@fujita-hu.ac.jp

Sponsor
Institute Department of Gastroenterology
Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology
Fujita Health University School of Medicine
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
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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 03 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 03 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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