UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053017 |
|---|---|
| Receipt number | R000060480 |
| Scientific Title | Dynamics analysis study of RAS in colorectal cancer |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/12/06 09:39:50 |
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Basic information
Public title
Analysis of temporal and spatial diversity of RAS gene mutations in metastatic colorectal cancer
Acronym
Analysis of temporal and spatial diversity of RAS gene mutations in metastatic colorectal cancer
Scientific Title
Dynamics analysis study of RAS in colorectal cancer
Scientific Title:Acronym
Dynamics analysis study of RAS in colorectal cancer
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the temporal dynamics of RAS during treatment and its clinical significance by temporal monitoring of ctDNA RAS in mCRC patients with RAS MT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of NeoRAS wild-type
Key secondary outcomes
1. Percentage of RAS status mutations during chemotherapy.
2. Percentage of neo-RAS wild-type anti-EGFR antibodies used.
3. RAS mutation rates in tissue samples and liquid biopsy.
4. Overall survival, progression-free survival of neo RAS wild-type and RAS mutant
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with mCRC who have undergone or are undergoing chemotherapy (including the use of molecularly targeted drugs and immune checkpoint inhibitors).
Key exclusion criteria
Colitic cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Iguchi |
Organization
Kanagawa Cancer Center
Division name
Department of colorectal surgery
Zip code
241-8515
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
TEL
0455202222
igc.ken.surg@gmail.com
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Iguchi |
Organization
Kanagawa Cancer Center
Division name
Department of colorectal surgery
Zip code
241-5815
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
TEL
0455202222
Homepage URL
igc.ken.surg@gmail.com
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Kenta Iguchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
Tel
0455202222
clinical_trials@kcch.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 | 07 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060480
