UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013154
Receipt number 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 09:42:54

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
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