UMIN-CTR Clinical Trial

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