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
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
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
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
