UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053122 |
|---|---|
| Receipt number | R000060620 |
| Scientific Title | Verification of Colorectal Cancer Recurrence Prediction and Screening Capability Through Methylation Analysis of DNA in Plasma of SETOCHI Study Participants |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 17:53:18 |
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Basic information
Public title
Verification of Colorectal Cancer Recurrence Prediction and Screening Capability Through Methylation Analysis of DNA in Plasma of SETOCHI Study Participants
Acronym
SETOUCHI-Liquid Biopsy Study
Scientific Title
Verification of Colorectal Cancer Recurrence Prediction and Screening Capability Through Methylation Analysis of DNA in Plasma of SETOCHI Study Participants
Scientific Title:Acronym
SETOUCHI-Liquid Biopsy Study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to develop a 'Methylated CpG, micro RNA, and long non-coding RNA (lncRNA) Detection Platform' that does not rely on NGS, by utilizing biomarkers such as methylation CpG sites, micro RNA, and noncoding long fragment RNA, which are frequently observed in specific types of cancer. The goal is to verify the effectiveness of recurrence prediction and screening following curative resection of gastrointestinal cancers, and to construct new cancer detection technology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Verification of the effectiveness of recurrence prediction and early screening after curative resection, based on analysis results from Hi-SA method (Fragment Assay), DNA Chip (Gene Silicon), dPCR (QuantStudio Absolute Q Digital PCR System), and real-time PCR.
Key secondary outcomes
1) Setting the cutoff values in Hi-SA method (Fragment Assay), DNA Chip (Gene Silicon), dPCR (QuantStudio Absolute Q Digital PCR System), and real-time PCR.
2) Elucidation of the interrelationships in the results of Hi-SA method (Fragment Assay), DNA Chip (Gene Silicon), dPCR (QuantStudio Absolute Q Digital PCR System), and real-time PCR.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Targeting participants who participated in the SETOUCHI Study.
Key exclusion criteria
None
Target sample size
452
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
takeshin@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Takeshi Nagasaka
Funding Source
Organization
kawasakiMedical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki-city, Okayama
Tel
0864621111
takeshin@med.kawasaki-m.ac.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 | 12 | Month | 15 | 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
| 2013 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This trial is an observational study
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
