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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027296
Receipt No. 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 2019/05/12

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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
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 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 Open public recruiting
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
2020 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
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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