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UMIN-CTR Clinical Trial |
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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 | 2020/06/12 |
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 |
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Condition | ||
Condition | Colorectal Neoplasm | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
tamatsud@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |
2020/09/29 | ★JPS Protocol.pdf |
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 |