UMIN-CTR Clinical Trial

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
Email	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
Email	kota.ouchi.b3@tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047052