UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053340 |
|---|---|
| Receipt number | R000060883 |
| Scientific Title | A retrospective observational study of biomarkers in a phase III clinical trial (TRICOLORE study) in the primary treatment of metastatic colorectal cancer |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/05/31 11:38:17 |
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Basic information
Public title
A retrospective observational study of biomarkers in a phase III clinical trial (TRICOLORE study) in the primary treatment of metastatic colorectal cancer
Acronym
A retrospective observational study of biomarkers in the primary treatment of metastatic colorectal cancer
Scientific Title
A retrospective observational study of biomarkers in a phase III clinical trial (TRICOLORE study) in the primary treatment of metastatic colorectal cancer
Scientific Title:Acronym
A retrospective observational study of biomarkers in the primary treatment of metastatic colorectal cancer
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to identify biomarkers that can predict treatment response, adverse events, and patient quality of life (QoL) in patients with metastatic colorectal cancer using omics and clinical data, and to test whether the efficacy of primary chemotherapy can be predicted in terms of treatment response, adverse events, and patient QoL.
Basic objectives2
Others
Basic objectives -Others
The objective is to identify novel biomarkers and validate their usefulness.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Explore novel biomarker-based subtype classification using machine learning causal effect analysis techniques.
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
Of the patients enrolled in the TRICOLORE study, those who have given consent for ancillary research and for whom various omics data are available will be enrolled in this study.
Key exclusion criteria
not applicable
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Chikashi |
| Middle name | |
| Last name | Ishioka |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Clinical Oncology,
Zip code
980-8575
Address
4-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-8543
chikashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Ouchi |
Organization
Tohoku University Hospital
Division name
Department of Medical Oncology
Zip code
980-8575
Address
4-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-8543
Homepage URL
kota.ouchi.b3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi, Ltd.
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 01 | Month | 12 | 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
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | 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
This study uses omics and clinical data with metastatic colorectal cancer to identify biomarkers that can predict treatment response, adverse events, and patient QoL in these patients, and to test whether the efficacy of primary chemotherapy can predict treatment response, adverse events, and patient QoL.
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060883
