UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040731 |
|---|---|
| Receipt number | R000046507 |
| Scientific Title | A multicenter cohort study to elucidate the effect of endoscopic polypectomy on the incidence of colorectal cancer- the Japan Polyp Study Cohort |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/06/12 15:42:40 |
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Basic information
Public title
A multicenter cohort study to elucidate the effect of endoscopic polypectomy on the incidence of colorectal cancer- the Japan Polyp Study Cohort
Acronym
Japan Polyp Study (JPS) Cohort
Scientific Title
A multicenter cohort study to elucidate the effect of endoscopic polypectomy on the incidence of colorectal cancer- the Japan Polyp Study Cohort
Scientific Title:Acronym
Japan Polyp Study (JPS) Cohort
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of reduction for colorectal cancer incidence and mortality by endoscopic polypectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of invasive cancer at 6, 9 and 12 years after clean colon (Complete removal of colorectal neoplasia)
Key secondary outcomes
1) Incidence of index lesions (ILs: large adenoma >10 mm, high-grade adenoma, cancer) at 6, 9 and 12 years after clean colon (Complete removal of colorectal neoplasia)
2) Effect of reduction for colorectal cancer mortality by endoscopic polypectomy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Japan Polyp Study enrolled patients who are considered to be available until the completion of the cohort study
Key exclusion criteria
1. Informed Consent (IC) refusal example
2. Subjects with serious comorbidities (active other organ cancer, severe chronic heart failure, renal failure, liver failure, etc.)
3. When the doctor in charge determines that the registration for this study is inappropriate
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Matsuda |
Organization
National Cancer Center Hospital, Tokyo
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Mori |
Organization
National Cancer Center Hospital, Tokyo
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
mmori@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center, National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Japan Polyp Study Workgroup
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
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
国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、大阪国際がんセンター（大阪府）、服部胃腸科・尾田胃腸内科（熊本県）、昭和大学病院（東京都）、昭和大学横浜市北部病院（神奈川県）、北里大学病院（神奈川県）、栃木県立がんセンター（栃木県）、藤井隆広クリニック（東京都）、JA長野厚生連佐久総合病院（長野県）、静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1291
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
| 2008 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2008 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2027 | 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
Research progress is as planned.
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046507
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/06/12 | ★JPS2041名 コホートデータ_UMIN登録用.xlsx |
