Unique ID issued by UMIN | C000000058 |
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Receipt number | 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 | 2021/08/24 17:50:50 |
A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study
The Japan Polyp Study
A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study
The Japan Polyp Study
Japan |
Colorectal Neoplasm
Gastroenterology |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Not applicable
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.
Colorectal cancer morbidity and mortality
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as a block.
Central registration
2
Prevention
Maneuver |
1, 3 year follow-up after two complete colonoscopies with the removal of all polyps detected
3 year follow-up after two complete colonoscopies with the removal of all polyps detected
40 | years-old | <= |
69 | years-old | >= |
Male and Female
Patients who undergo colonoscopy.
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.
3000
1st name | Takahisa |
Middle name | |
Last name | Matsuda |
National Cancer Center Hospital (NCCH)
Cancer Screening Center/ Endoscopy division
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
tamatsud@ncc.go.jp
1st name | Mika |
Middle name | |
Last name | Mori |
National Cancer Center Hospital (NCCH)
Cancer Screening Center/ Endoscopy division
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
http://www.jps21.jp/
mmori@ncc.go.jp
The Japan Polyp Study (JPS) Workgroup
Ministry of Health, Labour and Welfare, Japan
Japanese Governmental office
national Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo
03-3542-2511
tamatsud@ncc.go.jp
NO
2005 | Year | 08 | Month | 12 | Day |
Published
https://pubmed.ncbi.nlm.nih.gov/33139269/
3926
The present study demonstrated the equivalent accuracy of detecting AN with a single surveillance colonoscopy at 3 years, compared to two surveillance colonoscopies at 1 and 3 years post-polypectomy, even considering NP-CRNs. Even after a two-round baseline colonoscopy, AN mainly composed of NP-CRNs, especially, LST-NG were detected at follow-up colonoscopy. AN were more frequently detected in individuals in whom LST-NG had been treated at baseline colonoscopy.
2021 | Year | 08 | Month | 24 | Day |
2020 | Year | 11 | Month | 02 | Day |
40-69 years old who visited the hospital for colonoscopy at 11 institutions (excluding cases with familial adenomatous polyposis, Lynch syndrome, inflammatory bowel disease, and history of colorectal cancer surgery)
After enrollment, participants underwent a two-round baseline colonoscopy (1st- and 2nd-colonoscopy; interval: 1 year).After the two-round baseline colonoscopy, the patients were randomly assigned to undergo follow-up colonoscopies at 1 and 3 years (2-exam group) or at 3 years only (1-exam group).
No significant Adverse events
Prevalence of metachronous advanced neoplasia (AN: adenoma of 10 mm or more, high-grade dysplasia, cancer) occurring in 3 years after random allocation
No plan
Main results already published
2002 | Year | 11 | Month | 26 | Day |
2002 | Year | 11 | Month | 26 | Day |
2003 | Year | 02 | Month | 01 | Day |
2025 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2027 | Year | 09 | Month | 30 | Day |
2028 | Year | 09 | Month | 30 | Day |
2005 | Year | 08 | Month | 12 | Day |
2021 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000102
Research Plan | |
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Registered date | File name |
2020/09/29 | ★JPS Protocol.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2017/11/15 | ★JPS2041名 コホートデータ_UMIN登録用.xlsx |