UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032061 |
|---|---|
| Receipt number | R000036572 |
| Scientific Title | Computed Tomography Colonography with/without DIET restriction. a randomised control trial |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2019/10/07 15:28:09 |
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Basic information
Public title
Computed Tomography Colonography with/without DIET restriction. a randomised control trial
Acronym
CTC diet study
Scientific Title
Computed Tomography Colonography with/without DIET restriction. a randomised control trial
Scientific Title:Acronym
CTC diet study
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quality evaluation of diet restriction bowel preparations in CT colonography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The influence of diet restriction on quality of bowel preparation in CT colonography using a reduced bowelpreparation, including tagging quality of bowel preparation, volume of residual fluids and feces.
Key secondary outcomes
The assessment patients' tolerance of the assigned dietary regimen using visual analogue scale (VAS) and a questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
CT colonography scanning with no diet restriction.
Interventions/Control_2
CT colonography scanning with dietary instruction.
Interventions/Control_3
CT colonography scanning with low residue diet.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patient for diagnostic evaluation.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 40 years or older.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria
1) Inflammatory bowel disease.
2) FAP (familial adenomatous polyposis) or HNPCC (hereditary non polyposis colon cancer, Amsterdam criteria)
3) High risk for bowel preparation or CTC exams by renal dysfunction.
4) Severe thyroid disease.
5) History of bowel resection.
6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
7) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
8) Possibility of pregnancy.
9) Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
10) Claustrophobia.
11) Severe deafness.
12) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Matsuoka |
Organization
Matsuoka Clinic
Division name
Chief of Medical Clinic
Zip code
636-0002
Address
2-9-15, Oji, Oji-cho, Kita-katsuragi-gun, Nara 636-0002 Japan
TEL
+81-0745-33-1500
m.matsuoka@matsuoka-clinic.net
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Nagata |
Organization
National Cancer Center
Division name
Cancer Screening Center
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL
+81-3-3542-2511
Homepage URL
Nagata7@aol.com
Sponsor or person
Institute
Matsuoka Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsuoka Clinic Institutional Review Board
Address
2-9-15, Oji, Oji-cho, Kita-katsuragi-gun, Nara 636-0002 Japan
Tel
+81-0745-33-1500
j.ina@matsuoka-clinic.net
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
医療法人まつおかクリニック（奈良県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036572
