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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025983
Receipt No. R000029870
Scientific Title Diagnosis of colorectal cancer by circulating tumor DNA
Date of disclosure of the study information 2017/02/06
Last modified on 2017/02/03

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Basic information
Public title Diagnosis of colorectal cancer by circulating tumor DNA
Acronym Diagnosis of colorectal cancer by circulating tumor DNA
Scientific Title Diagnosis of colorectal cancer by circulating tumor DNA
Scientific Title:Acronym Diagnosis of colorectal cancer by circulating tumor DNA
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to address that circulating tumor DNA (p53, K-ras, B-raf, PIK3CA) and tumor DNA (p53, K-ras, B-raf, PIK3CA) in exosome before and after therapy including chemotherapy, chemoradiation therapy and surgery indicate status of colorectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between prognosis and circulating tumor DNA (p53, K-ras, B-raf, PIK3CA) and tumor DNA (p53, K-ras, B-raf, PIK3CA) in exosome before and after therapy including chemotherapy, chemoradiation therapy and surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria #1 diagnosed colorectal cancer by colonoscopy, computed tomography, and magnetic resonance imaging.
#2 Age of patient is over 20 years old.
#3 Informed consent can be obtained.
Key exclusion criteria #1 Informed consent can not be obtained.
#2 Doctor recognizes that patient is not suitable for this study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Yokoyama
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Email yokoyama@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shozo Yokoyama
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Homepage URL
Email yokoyama@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, Second Department of Surgery
Institute
Department

Funding Source
Organization Wakayama Medical University, Second Department of Surgery
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
2017 Year 02 Month 06 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
Date of protocol fixation
2017 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study has just started.

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029870

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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