UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041205 |
|---|---|
| Receipt number | R000047052 |
| Scientific Title | A retrospective study to evaluate the predictive ability of a DNA methylation status-based diagnostic method for the sensitivity of anti-EGFR treatment in metastatic colorectal cancer |
| Date of disclosure of the study information | 2020/07/24 |
| Last modified on | 2022/07/26 16:51:59 |
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Basic information
Public title
A retrospective study to evaluate the predictive ability of a DNA methylation status-based diagnostic method for the sensitivity of anti-EGFR treatment for metastatic colorectal cancer
Acronym
Observational study on a method for predicting the efficacy of anti-EGFR treatment for colorectal cancer
Scientific Title
A retrospective study to evaluate the predictive ability of a DNA methylation status-based diagnostic method for the sensitivity of anti-EGFR treatment in metastatic colorectal cancer
Scientific Title:Acronym
Observational study on a method for predicting the efficacy of anti-EGFR treatment 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 study is to verify whether measuring DNA methylation status is predictive of anti-EGFR antibody drug sensitivity in RAS wild-type colorectal cancer, and to compare this with prediction of treatment response by primary site.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS (Progression Free Survival)
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 with colorectal cancer who failed standard primary and secondary treatment without anti-EGFR antibody drugs and were treated with anti-EGFR antibody drugs in combination with irinotecan on tertiary therapy.
Key exclusion criteria
Patients who received anti-EGFR antibodies in the first or second line of treatment.
Cases in which the patient is unable to submit the required amount of tissue samples from the primary tumor for measurement of methylation status.
Cases considered by the attending physician to be unsuitable for enrollment in this study.
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35612620/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35612620/
Number of participants that the trial has enrolled
241
Results
DNA methylation status may be a predictor of therapeutic response to anti-EGFR antibody drugs in the first-line treatment of metastatic colorectal cancer.
Results date posted
| 2022 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with metastatic colorectal cancer who received anti-EGFR antibody therapy in primary or secondary treatment
Participant flow
The course of treatment of the above subject patients was collected on a medical record basis.
Adverse events
No evaluation due to retrospective analysis
Outcome measures
Progression-free survival, overall survival, response rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047052
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