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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000013680
Receipt No. R000015972
Scientific Title Diagnosis of colorectal cancer by serum and exosomal CEA family and detection of circulating tumo cells
Date of disclosure of the study information 2014/04/14
Last modified on 2017/02/03

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Basic information
Public title Diagnosis of colorectal cancer by serum and exosomal CEA family and detection of circulating tumo cells
Acronym Diagnosis of colorectal cancer by CEA family and circulating tumo cells
Scientific Title Diagnosis of colorectal cancer by serum and exosomal CEA family and detection of circulating tumo cells
Scientific Title:Acronym Diagnosis of colorectal cancer by CEA family and circulating tumo cells
Region
Japan

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

Objectives
Narrative objectives1 More excellent tumor marker for colorectal cancer is required for exact diagnosis of malignant phenotype of colorectal cancer. In the present study, novel tumor marker for colorectal cancer and new technique for detection of circulating tumor cells are explored. Moreover, the relatiosn between these marker and clinicopathological features of patients with colorectal cancer are investigated.
Basic objectives2 Others
Basic objectives -Others Diagnosis by novel tumor marker
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prediction of malignant phenotype of colorectal cancer by serum and exosomal CEA family and detection of circulating tumor cells.
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 Colorectal cancer patients with informed consent agreement
Key exclusion criteria Colorectal cancer patients without informed consent agreement
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Yokoyama
Organization Wakayama Medical University, School of Medicine
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, School of Medicine
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, School of Medicine
Institute
Department

Funding Source
Organization Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 14 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
2014 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preinitiation

Management information
Registered date
2014 Year 04 Month 10 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=R000015972

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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