UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic Research for Population-Based Colorectal Cancer Screening Targeted an Isolated Island: Niijima Study
Title of the study (Brief title)	NIIJIMA STUDY
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Establishment for the ideal model of colorectal cancer screening in the isolated island
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of colorectal cancer screening
Key secondary outcomes	Improve effectiveness for prevalence of colorectal cancer screening by call-recall method

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	FOBT/Total Colonoscopy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	All people between 40 and 79 years who lives in Niijima island.
Key exclusion criteria	Over 80 years
Target sample size	700

Research contact person
Name of lead principal investigator	Takahisa Matsuda
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	Takahisa Matsuda
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	tamatsud@ncc.go.jp

Sponsor
Institute	Niijima Study Working Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grants-in Aid for Clinical Cancer Research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立がん研究センター中央病院（National Cancer Center Hospital）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 25 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 17 Day
Last modified on	2016 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006955