UMIN-CTR Clinical Trial

Basic information
Public title	Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Acronym	Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Scientific Title	Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Scientific Title:Acronym	Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate predicting biomarker for anti-EGFR(Epidermal Grouwth Factor Receptor) antibody
Basic objectives2	Others
Basic objectives -Others	Incidence and location of gene mutation corresponding to response to anti-EGFR antibody
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence and location of gene mutation corresponding to response to anti-EGFR antibody
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patient with histologically confirmed primary adenocarcinoma. 2)Patient with advanced or recurrent colorectal carcinoma. 3)Patient with KRAS exon2 codon12/13 wild colorectal cancer. 4)Patient with lesion confirmed by imaging tests before chemotherapy. 5)Patient with metastatic colorectal cancer with measurable lesion according to RECIST ver.1.1 6)Patients who plan to receive chemotherapy including anti-EGFR antibody. 7)Patients who plan to receive imaging tests within 3 months after commencement of chemotherapy. 8)Age over 20. 9)Patient with metastatic colorectal cancer whose paraffin-embedded samples were obtained enough at St Marianna University School of Medicine Hospital . 10) Patient with written informed consent. 11) Patient who can provide bloody specimens before chemotherapy.
Key exclusion criteria	1) Patient with simultaneous or metachronous double cancers except carcinoma in situ or intramucosal tumor. 2) Patient with active bacterial or fungous infection. 3) Patient with uncontrollable pleural effusion or ascites. 4) Patient with history of interstitial neumonitis to pulmonary fibrosis. 5) Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takuro Middle name Last name Mizukami
Organization	St. Marianna University School of Medicine
Division name	Department of clinical oncology
Zip code	2168511
Address	2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
TEL	0449778111
Email	t3mizukami@marianna-u.ac.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Mizukami
Organization	St. Marianna University School of Medicine
Division name	Department of clinical oncology
Zip code	2168511
Address	2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
TEL	0449778111
Homepage URL
Email	t3mizukami@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kinki University School of Medicine, Department of Genome Biology
Name of secondary funder(s)	Kinki University School of Medicine, Department of Genome Biology

IRB Contact (For public release)
Organization	St Marianna University School of Medicine
Address	2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
Tel	044-977-8111
Email	t3mizukami@marianna-u.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	聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 15 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	40
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	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 08 Day
Date of IRB	2014 Year 04 Month 08 Day
Anticipated trial start date	2014 Year 04 Month 16 Day
Last follow-up date	2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analysis of incidence and location of gene mutation corresponding to response to anti-EGFR antibody

Management information
Registered date	2014 Year 04 Month 15 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016014