UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020277 |
|---|---|
| Receipt number | R000023409 |
| Scientific Title | Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker |
| Date of disclosure of the study information | 2015/12/19 |
| Last modified on | 2021/12/23 09:21:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker
Acronym
Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker(Oshima Study)
Scientific Title
Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker
Scientific Title:Acronym
Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker(Oshima Study)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We carry out the screening colonoscopy and perform an evaluation the effectiveness of the newly developed biomarker by using blood and stool sample.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic sensitivity, specificity, PPV, NPV and overall accuracy of the FIT and newly developed biomarker for colorectal cancer and precancerous lesions (so called advanced adenoma, >10mm, HGD).
Key secondary outcomes
Safety and effectiveness of screening colonoscopy(complication rate, CRC detection rate and adenoma detection rate: ADR).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Total colonoscopy, FIT and Blood test will be provided once for all participants.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Residents in Oshima-machi, Tokyo
Key exclusion criteria
Non-assentor
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
Division name
Cancer Screening Center
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Matsuda |
Organization
National Cancer Center Hospital
Division name
Cancer Screening Center
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tamatsud@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立がん研究センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33939384/
Number of participants that the trial has enrolled
1367
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023409
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/06/27 | ★大島STUDY 研究実施計画書（第13版）.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/12/13 | ★大島STUDY_miRNAデータ_20171213.xlsx |
