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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038575
Receipt No. R000043948
Scientific Title Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation
Date of disclosure of the study information 2019/11/13
Last modified on 2020/05/14

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Basic information
Public title Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation
Acronym Evaluation of RAS gene status in ctDNA for colorectal cancer patients with RASg gene mutation
Scientific Title Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation
Scientific Title:Acronym Evaluation of RAS gene status in ctDNA for colorectal cancer patients with RASg gene mutation
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the allele frequency of RAS gene mutation in circulating tumor DNA for metastatic colorectal cancer patients who previously were treated with standard chemotherapy
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the allele frequency of RAS gene mutation in circulating tumor DNA
Key secondary outcomes

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 1) Patients with histopathologically confirmed unresecable or metastatic colorectal adenocarcinoma
2) Wild-type RAS status
3) Patients with refractory or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin and bevacizumab), and refractory to anti-EGFR antibodies (cetuximab and panitumumab)
Key exclusion criteria No willingness to sign a written informed consent documen
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yu
Middle name
Last name Sunakawa
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code 2160015
Address 2-16-1 Sugao Miyamaeku, Kawasaki
TEL 0449778111
Email y.sunakawa@marianna-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Izawa
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code 2160015
Address 2-16-1 Sugao Miyamaeku, Kawasaki
TEL 0449778111
Homepage URL
Email n2izawa@gmail.com

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 Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1 Sugao Miyamaeku, Kawasaki
Tel 0449778111
Email k-sienbu.mail@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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 13 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 Enrolling by invitation
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
2019 Year 11 Month 08 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no special comments

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043948

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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