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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024954
Receipt No. R000028683
Scientific Title Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer (additional resaerch B)
Date of disclosure of the study information 2016/11/24
Last modified on 2019/03/08

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Basic information
Public title Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer (additional resaerch B)
Acronym JACCRO CC-05/CC-06 AR B
Scientific Title Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer (additional resaerch B)
Scientific Title:Acronym JACCRO CC-05/CC-06 AR B
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to re-analysis of relations between individual biomarker and clinical data using JACCRO CC-05AR (UMIN000004197) and CC-06 studies(UMIN00007022).
Basic objectives2 Others
Basic objectives -Others We investigate biomarker as below;Gene expression of EGFR, Gene amplification, EGFR intron 1 CA repeat number, Ligand expression to EGFR, expressions of epiregulin, amphiregulin, BRAF, P13K, PTEN, BRAF 600E, P13KCA exon9/exon20 and ERCC1. Around 2,500 Gene expression analyse using HTG EdgeSeq Oncology Biomarker Panel (HTG Molecular Diagnositics, Inc.)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the biomarkers and the response to cetuximab containing combination therapies.
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) Patients who were treated in JACCRO CC-05 study (UMIN000004197) and in JACCRO CC-06 study (UMIN000007022) .
(2) Patients who have the paraffin-embedded section of tumor tissue.
(3) Approved to supply the sections for this research by IRB.
(4) Obtained the informed consent from the patient, if in the case of death or disappearance, approval of IRB or the representative of hospital must be taken.
Key exclusion criteria (1) Patients who are regarded as inadequate for study enrollment by investigators (2) Patients who refuse to supply the section
Target sample size 77

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Ichikawa
Organization Showa University Fujigaoka Hospital
Division name Division of Medical Oncology and Palliative Medicine
Zip code
Address 1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL 045-971-1151
Email wataru@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email cc05cc06ar@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 24 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
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 09 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information The purpose of this study is to re-analysis of relations between individual biomarker and clinical data using JACCRO CC-05AR (UMIN000004197) and CC-06 studies(UMIN00007022).
We investigate biomarker as below;Gene expression of EGFR, Gene amplification, EGFR intron 1 CA repeat number, Ligand expression to EGFR, expressions of epiregulin, amphiregulin, BRAF, P13K, PTEN, BRAF 600E, P13KCA exon9/exon20 and ERCC1. Around 2,500 Gene expression analyse using HTG EdgeSeq Oncology Biomarker Panel (HTG Molecular Diagnositics, Inc.)

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028683

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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