UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013680 |
|---|---|
| Receipt number | 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 11:50:21 |
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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
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
yokoyama@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015972
