UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000058 |
|---|---|
| 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 |
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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
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
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/
mmori@ncc.go.jp
Sponsor or person
Institute
The Japan Polyp Study (JPS) Workgroup
Institute
Department
Personal name
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
| 2005 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33139269/
Number of participants that the trial has enrolled
3926
Results
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.
Results date posted
| 2021 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
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)
Participant flow
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).
Adverse events
No significant Adverse events
Outcome measures
Prevalence of metachronous advanced neoplasia (AN: adenoma of 10 mm or more, high-grade dysplasia, cancer) occurring in 3 years after random allocation
Plan to share IPD
No plan
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.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 |
