UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study
Acronym	The Japan Polyp Study
Scientific Title	A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study
Scientific Title:Acronym	The Japan Polyp Study
Region	Japan

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

Objectives
Narrative objectives1	1) The overall objective of the JPS is a multicenter randomized controlled trial designed to evaluate follow-up surveillance strategies in patients who have undergone two complete colonoscopies for the control of colorectal cancer, with the removal of all detected polyps by high-resolution chromoendoscopy, including the removal of flat or depressed lesions. 2) To evaluate the effect of endoscopic polypectomy on morbidity and mortality of colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary goal is to address the hypothesis that after two complete colonoscopies with the removal of all polyps detected, the incidence of clinically significant lesions would not be different between patients undergoing two further follow-up examinations and those undergoing just one. Clinically significant lesions are defined as index lesions (IL): if they are larger than 10mm; if they have high-grade dysplasia; or if they are invasive.
Key secondary outcomes	Colorectal cancer morbidity and mortality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	1, 3 year follow-up after two complete colonoscopies with the removal of all polyps detected
Interventions/Control_2	3 year follow-up after two complete colonoscopies with the removal of all polyps detected
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo colonoscopy.
Key exclusion criteria	Patients who have a family or personal history of familial polyposis, HNPCC, inflammatory bowel disease, or a personal history of polypectomy with unknown histology, who have not had invasive colorectal cancer or colectomy have been considered for exnclusion.
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Takahisa Middle name Last name Matsuda
Organization	National Cancer Center Hospital (NCCH)
Division name	Cancer Screening Center/ Endoscopy division
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	1st name Mika Middle name Last name Mori
Organization	National Cancer Center Hospital (NCCH)
Division name	Cancer Screening Center/ Endoscopy division
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL	http://www.jps21.jp/
Email	mmori@ncc.go.jp

Sponsor
Institute	The Japan Polyp Study (JPS) Workgroup
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	national Cancer Center Hospital
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	tamatsud@ncc.go.jp

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

Other administrative information
Date of disclosure of the study information	2005 Year 08 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	3926
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	2002 Year 11 Month 26 Day
Date of IRB	2002 Year 11 Month 26 Day
Anticipated trial start date	2003 Year 02 Month 01 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry	2026 Year 09 Month 30 Day
Date trial data considered complete	2027 Year 09 Month 30 Day
Date analysis concluded	2028 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2005 Year 08 Month 12 Day
Last modified on	2020 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000102

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2017/11/15	★JPS2041名 コホートデータ_UMIN登録用.xlsx

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