UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031279