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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032061
Receipt No. 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

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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
Email 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
Email Nagata7@aol.com

Sponsor
Institute Matsuoka Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036572

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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