UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027296 |
|---|---|
| Receipt number | R000031279 |
| Scientific Title | Observational study on clinical outcome prediction of anti-epidermal growth factor receptor for colorectal cancer based on DNA methylation status and gene expression status. |
| Date of disclosure of the study information | 2017/05/11 |
| Last modified on | 2022/11/13 09:10:35 |
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Basic information
Public title
Observational study on clinical outcome prediction of anti-epidermal growth factor receptor for colorectal cancer based on DNA methylation status and gene expression status.
Acronym
Observational study on clinical outcome prediction of anti-epidermal growth factor receptor for colorectal cancer.
Scientific Title
Observational study on clinical outcome prediction of anti-epidermal growth factor receptor for colorectal cancer based on DNA methylation status and gene expression status.
Scientific Title:Acronym
Observational study on clinical outcome prediction of anti-epidermal growth factor receptor for colorectal cancer.
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to clarify the following items.
1. Verify that the therapeutic effect of anti-EGFR antibody drug can be predicted by methylation status.
2. Search for genes whose expression status is related to the therapeutic sensitivity of anti-EGFR antibody drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
PFS (Progression Free Survival) / RR (Response Rate)
Key secondary outcomes
OS (Overall Survival)
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
This study designed for KRAS wild-type metastatic colorectal cancer patients who received anti-EGFR treatment.
Key exclusion criteria
Cases with mutations in KRAS are excluded from the subject.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chikashi |
| Middle name | |
| Last name | Ishioka |
Organization
Institute of Development, Aging and Cancer (IDAC)
Division name
Department of Clinical Oncology
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 9808575, Japan.
TEL
+81-22-717-8543
chikashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Ouchi |
Organization
Institute of Development, Aging and Cancer (IDAC)
Division name
Department of Clinical Oncology
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 9808575, Japan.
TEL
+81-22-717-8543
Homepage URL
kota.ouchi.b3@tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Ethics Committees of Tohoku University School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 9808575, Japan.
Tel
+81-22-717-7000
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
東北大学病院（宮城県）/ Tohoku University Hospital (Miyagi)、大崎市民病院（宮城県）/ Osaki Citizen Hospital (Miyagi)、石巻赤十字病院（宮城県）/ Japanese Red Cross Ishinomaki Hospital (Miyagi)、仙台オープン病院（宮城県）/ Sendai Open Hospital (Miyagi)、茨城県立中央病院（茨城県）/ Ibaraki Prefectural Central Hospital (Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
159
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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We verify that clinical outcomes of anti-EGFR antibody differ between the two groups defined by the methylation-based classification method.
Management information
Registered date
| 2017 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031279
