UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056739 |
|---|---|
| Receipt number | R000064789 |
| Scientific Title | Introduction of Novel Liquid Biopsy in Genomic Medicine |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2025/12/10 13:10:33 |
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Basic information
Public title
Introduction of Novel Liquid Biopsy in Genomic Medicine
Acronym
Novel Liquid Biopsy in Genomic Medicine
Scientific Title
Introduction of Novel Liquid Biopsy in Genomic Medicine
Scientific Title:Acronym
Novel Liquid Biopsy in Genomic Medicine
Region
| Japan |
Condition
Condition
Malignant tumor
Healthy person
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Urology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Operational evaluation of two types of liquid biopsy offered by GC genome
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Operational evaluation of two types of liquid biopsy
Key secondary outcomes
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
･Patients or healthy persons visiting Seta Clinic Tokyo who wish to undergo "DNA CT" or "ai-CANCERCH" testing.
･Patients or healthy persons who, after having been fully informed of the study and with sufficient understanding, have given their free and voluntary written consent to participate in the study.
Key exclusion criteria
･Patients or healthy persons who are judged to be inappropriate as test subjects by the Principal Investigator or Research Assistants.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamigaki |
Organization
Seta Clinic Tokyo
Division name
Center for Clinical Trials and Research
Zip code
101-0062
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, JAPAN
TEL
03-5280-0086
info@j-immunother.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ibe |
Organization
Seta Clinic Tokyo
Division name
Center for Clinical Trials and Research
Zip code
101-0062
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, JAPAN
TEL
03-5244-5751
Homepage URL
citeg@j-immunother.com
Sponsor or person
Institute
Seta Clinic Tokyo
Institute
Department
Personal name
Funding Source
Organization
GC LYMPHOTEC
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seta Clinic Group Certified Committee for Regenerative Medicine
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, JAPAN
Tel
03-5244-5751
ccrm@j-immunother.com
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
| 2026 | Year | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, liquid biopsy was performed on patients with malignant tumors and healthy donors.
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064789
