UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018598
Receipt No. R000018507
Scientific Title Benchmark values of CT colonography reporting and data system(C-RADS) on clinical colorectal screening program
Date of disclosure of the study information 2015/08/10
Last modified on 2020/02/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Benchmark values of CT colonography reporting and data system(C-RADS) on clinical colorectal screening program
Acronym Benchmark values of CT colonography reporting and data system(C-RADS) on clinical colorectal screening program
Scientific Title Benchmark values of CT colonography reporting and data system(C-RADS) on clinical colorectal screening program
Scientific Title:Acronym Benchmark values of CT colonography reporting and data system(C-RADS) on clinical colorectal screening program
Region
Japan

Condition
Condition colorectal neoplasma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to establish baseline CRADS valures for CTC screening
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes baseline CRADS valures for CTC screening
Key secondary outcomes the efficaciy of CTC screening program in japan

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria FOBT positive patients
Key exclusion criteria patients have colorectal disease: colorectal polyps, cancer, inflammatory bowel disease.
high risk patients of colorectal cancer; FAP, HNPCC family history
patients have risk factor against CT colonography: ileus, perforation of colon, post operation status
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Division of Gastroenterology
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Email hmatsumoto0311@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Division of Gastroenterology
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Homepage URL
Email hmatsumoto0311@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
Email

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)、倉敷第一病院(岡山)、倉敷成人病センター(岡山)、笠岡第一病院(岡山)、しげい病院(岡山)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 10 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 Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 09 Month 01 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 02 Month 10 Day

Other
Other related information we have a plan to analysis about first 100 cases.

Management information
Registered date
2015 Year 08 Month 08 Day
Last modified on
2020 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.