UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059801 |
|---|---|
| Receipt number | R000068316 |
| Scientific Title | Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/17 13:55:21 |
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Basic information
Public title
Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer
Acronym
Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer
Scientific Title
Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer
Scientific Title:Acronym
Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To characterize changes in genomic alterations before and after chemotherapy using data from the PARADIGM trial, evaluate the effect of treatment on these changes, and investigate their association with patient outcomes.
Basic objectives2
Others
Basic objectives -Others
Investigation of ctDNA genomic alterations associated with treatment resistance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of genomic alterations between tumor tissue and ctDNA before treatment initiation
Changes in ctDNA genomic alterations before and after treatment
Impact of treatment regimen and treament duration on changes in ctDNA genomic alterations
Association between ctDNA genomic alterations and patient survival before and after treatment
Characterization of clinical features in cases harboring multiple genomic alterations
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
1) Patients who participated in the main study of the PARADIGM trial and provided consent for ancillary studies.
2) Patients enrolled in the PARADIGM trial between May 2015 and June 2017.
3) Patients whose study information has been disclosed through an opt-out process and who have not declined participation.
Key exclusion criteria
Patients who were excluded from data analysis in the PARADIGM trial
Target sample size
790
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kataoka |
Organization
National Cancer Center Research Institute
Division name
Division of Molecular Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
03-3542-2511
kekataok@ncc.go.jp
Public contact
Name of contact person
| 1st name | Sara |
| Middle name | |
| Last name | Horie |
Organization
National Cancer Center Research Institute
Division name
Division of Molecular Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
03-3542-2511
Homepage URL
sahorie@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AMED
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 Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.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
| 2025 | Year | 11 | Month | 18 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational study
Inclusion criteria:
1) Patients who participated in the main study of the PARADIGM trial and provided consent for ancillary studies.
2) Patients enrolled in the PARADIGM trial between May 2015 and June 2017.
3) Patients whose study information has been disclosed through an opt-out process and who have not declined participation.
Management information
Registered date
| 2025 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068316
