UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012747 |
|---|---|
| Receipt number | 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 16:29:18 |
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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
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
chiken@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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