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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013154
Receipt No. R000015337
Scientific Title A clinical study of relevance to KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
Date of disclosure of the study information 2014/04/01
Last modified on 2016/02/15

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Basic information
Public title A clinical study of relevance to KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
Acronym A relevance to KRAS mutations and acquired resistance to anti-EGFR therapy
Scientific Title A clinical study of relevance to KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
Scientific Title:Acronym A relevance to KRAS mutations and acquired resistance to anti-EGFR therapy
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It has been reported that kras mutatation has been emerged in kras wild type colorectal cancer after using anti-EGFR agent. By use of anti-EGFR agent, kras mutant selectively amplified, and then become resistance to anti-EGFR agent, from a part of colorectal cancer cells having kras mutation. In this study, we analyze kras mutation and other relative gene mutations in serum circulating DNA.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Detection of kras mutation in serum circulation DNA
Key secondary outcomes Detection of other mutations related colorectal cancer in serum circulation DNA

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Kras wild type advance or recurrent colorectal cancer and will be treated with an anti-EGFR antibody
Key exclusion criteria He or she had used anti-EGFR antibody previously, or prohibit on using anti-EGFR antibody
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Saijo
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Medical Oncology
Zip code
Address 1-757 Asahimachidori Chuohku, Niigata, 951-8510 Japan
TEL 025-368-9003
Email yasosj@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Saijo
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Medical Oncology
Zip code
Address 1-757 Asahimachidori Chuohku, Niigata, 951-8510 Japan
TEL 025-368-9003
Homepage URL
Email yasosj@med.niigata-u.ac.jp

Sponsor
Institute Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Niigata University Medical and Dental Hospital
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
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
2014 Year 04 Month 01 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 Completed
Date of protocol fixation
2012 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Detection of kras mutation in serum circulation DNA

Management information
Registered date
2014 Year 02 Month 13 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015337

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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