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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000058
Receipt No. R000000102
Scientific Title A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study
Date of disclosure of the study information 2005/08/12
Last modified on 2019/12/22

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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 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.
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 The secondary endpoint: Colorectal cancer reduction rate cause of endoscopic polypectomy

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 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 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) Working Group
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
2024 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 12 Day
Last modified on
2019 Year 12 Month 22 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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