UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050814 |
|---|---|
| Receipt number | R000057908 |
| Scientific Title | A Multicenter Observational Study for the Prevention of Colorectal Cancer Using the Existing Data from Participants in the Japan Polyp Study |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/11 13:28:30 |
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Basic information
Public title
A Multicenter Observational Study for the Prevention of Colorectal Cancer Using the Existing Data from Participants in the Japan Polyp Study
Acronym
Observational Study Using Existing JPS Data
Scientific Title
A Multicenter Observational Study for the Prevention of Colorectal Cancer Using the Existing Data from Participants in the Japan Polyp Study
Scientific Title:Acronym
Observational Study Using Existing JPS Data
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine risk factors for the development of colorectal carcinoma in patients with a history of colorectal cancer based on blood data.
This study aims to grasp the colonoscopy data in patients participating in the JPS as a historical control for the J-CAPP Study II.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploratory cohort analyses of blood data, alcohol intake, smoking, height, weight, BMI, and cumulative incidence of colorectal tumor
Key secondary outcomes
1)Interaction between blood data and the effectiveness of aspirin in preventing the development of ILs at 4 years
2)Interaction between alcohol intake and smoking status and the effectiveness of aspirin in preventing the development of ILs at 4 years
3)Interaction between height, weight, and BMI and the effectiveness of aspirin in preventing the development of ILs at 4 years
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
Patients who consented to participate in the JPS and have not refused the use of the existing data before the initiation of this study (3662 patients as of August 22, 2022). After consenting to participate in the JPS, 5 patients refused the use of all data, including past materials.
Key exclusion criteria
1. A history of colectomy (except appendectomy)
2. A history of endoscopic resection of colorectal epithelial tumor, except when detailed information on the previous lesion is confirmed (excluding patients with polyps not collected at the time of endoscopic resection and patients with cancer invading deeper than the submucosal layer even if surgery is not performed)
3. A history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) or current active infectious enteritis
4. Index patients or their family members of familial adenomatous polyposis (FAP), an extremely high-risk group of colorectal cancer, or hereditary nonpolyposis colorectal cancer (HNPCC)
Note: Regarding the diagnostic criteria for HNPCC, gastric cancer is added to HNPCC-related cancers, and a histological diagnosis is not required for a family history of cancer based on the Amsterdam diagnostic criteria II.
5. Serious complications (e.g., active cancer of other organs) who are not expected to survive for 5 years
6. Comorbidities (e.g., chronic blood disorder) precluding the achievement of a clean colon
Target sample size
3662
Research contact person
Name of lead principal investigator
| 1st name | Nozomu |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital
Division name
Director of Cancer Screening Center
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
nokobaya@ncc.go.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital
Division name
Director of Cancer Screening Center
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
nokobaya@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
nokobaya@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
| 2023 | Year | 05 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Multicenter Observational Study for the Prevention of Colorectal Cancer Using the Existing Data from Participants in the Japan Polyp Study
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057908
