UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028256 |
|---|---|
| Receipt number | R000021770 |
| Scientific Title | The novel diagnostic method of colorectal cancer by methyl mercaptan |
| Date of disclosure of the study information | 2017/07/16 |
| Last modified on | 2018/01/15 12:15:33 |
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Basic information
Public title
The novel diagnostic method of colorectal cancer by methyl mercaptan
Acronym
The novel diagnostic method of colorectal cancer by methyl mercaptan
Scientific Title
The novel diagnostic method of colorectal cancer by methyl mercaptan
Scientific Title:Acronym
The novel diagnostic method of colorectal cancer by methyl mercaptan
Region
| Japan |
Condition
Condition
The novel diagnostic method for colorectal cancer: Detection of methyl-mercaptan from flatus.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analysis the gas compounds from flatus of colorectal cancer patients and healthy controls to identify colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
To analysis correlation between colon cancer and each gas from flatus
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the amount of methylmercaptan from flatus
Key secondary outcomes
the amount of CO2, H2, H2S, CH4 from flatus
Correlation between colon cancer and each gas
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)Colorectal cancer
2)Written informed consent.
Key exclusion criteria
1)Infectious enteritis
2)Inframmatory bowel disease
3)Bowel obstruction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Ishibe |
Organization
Yokohama City University
Division name
Department of Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
0457872650
aishibe@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ishibe |
Organization
Yokohama City University
Division name
Department of Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
0457872650
Homepage URL
aishibe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2017 | Year | 07 | Month | 16 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
Everyone who met the selection criteria in patients who visited our institusion
Management information
Registered date
| 2017 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021770
