UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055029 |
|---|---|
| Receipt number | R000062866 |
| Scientific Title | Multicenter Observational Study on Screening for Cancer and Predicting Postoperative Recurrence Using Peripheral Blood Methylated DNA Analysis for Biomarker Discovery |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/10/08 17:10:50 |
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Basic information
Public title
Multicenter Observational Study on Screening for Cancer and Predicting Postoperative Recurrence Using Peripheral Blood Methylated DNA Analysis for Biomarker Discovery
Acronym
SETOUCHI-II
Scientific Title
Multicenter Observational Study on Screening for Cancer and Predicting Postoperative Recurrence Using Peripheral Blood Methylated DNA Analysis for Biomarker Discovery
Scientific Title:Acronym
SETOUCHI-II
Region
| Japan |
Condition
Condition
malignant tumors
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Aberrant DNA methylation is a common and early event in cancer development. Patients with cancer show unique methylation patterns and specific DNA methylation alterations in different cancer types. For example, SEPT9 and SFRP2 methylation abnormalities are frequent events in colorectal cancer and may serve as universal biomarkers for monitoring colorectal cancer patients. DNA methylation biomarkers can be a novel detection technology alongside genetic mutations in cancer screening, prognostic evaluation, evaluation of therapeutic efficacy, and personalized therapy.
In this study, we investigated whether the detection of abnormal cancer-specific methylation patterns in ccfDNA and peripheral blood leukocyte DNA using multiple tumor-specific methylation loci could be an effective biomarker for cancer screening and prediction of recurrence after curative resection not only in colorectal cancer but also in other malignant tumors. We will examine whether this could be a marker for cancer screening and prediction of recurrence after curative resection not only in colorectal cancer but also in other malignancies.
Basic objectives2
Others
Basic objectives -Others
To test whether the detection of ccfDNA and leukocyte DNA methylation in the blood of benign disease cases can be used to predict malignancy before the patient develops malignancy (preemptive medicine).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To verify whether "cancer screening" is possible by detecting ccfDNA and leukocyte DNA methylation in blood from patients undergoing upper and lower endoscopy and surgical procedures (benign and malignant diseases).
Key secondary outcomes
To test whether the detection of ccfDNA and leukocyte DNA methylation in postoperative blood of patients undergoing surgery for malignant diseases can be used to predict recurrence after curative resection.
To test whether the detection of ccfDNA and leukocyte DNA methylation in the blood of benign disease cases can be used to predict malignancy before the patient develops malignancy (preemptive medicine).
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
1) Cases where "cancer screening" is conducted through imaging or endoscopic examinations.
2) Cases for which written consent has been obtained from the patient or a legally authorized representative.
3) Cases judged to have a survival prognosis of more than one year from the date of registration.
Key exclusion criteria
1) Cases deemed inappropriate for participation in this study by the attending physician.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takehshi |
| 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
Research expenses are self-funded.
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
| 2024 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Observational Study
Management information
Registered date
| 2024 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062866
