UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035342 |
|---|---|
| Receipt number | R000040265 |
| Scientific Title | The relationship between colorectal tumor and bowel gas compound |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2021/05/11 15:23:24 |
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Basic information
Public title
The relationship between colorectal tumor and bowel gas compound
Acronym
The relationship between colorectal tumor and bowel gas compound
Scientific Title
The relationship between colorectal tumor and bowel gas compound
Scientific Title:Acronym
The relationship between colorectal tumor and bowel gas compound
Region
| Japan |
Condition
Condition
colorectal tumor
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,polyp and healthy controls
Basic objectives2
Others
Basic objectives -Others
To analysis the gas component from flatus of colorectal cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between gas component in colorectal cancer patients and healthy controls.
Key secondary outcomes
1.Correlation between gas component in colorectal polyp patients and healthy controls.
2.Correlation between gas component in colon cancer and polyp patients.
3.Colorectal cancer nomogram by gas component.
4.Differences between preoperative and postoperative gas component
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
a. Healthy control
1.No colorectal polyp in colonoscopy within the past 5 years.
2.No polypectomy or EMR for colorectal polyp within the past 5 years.
3. Written informed consent.
b.Colorectal polyp patient
1.Colorectal polyp
2.Written informed consent.
c.Colorectal cancer patient
1.Colorectal cancer
2.Written informed consent.
Key exclusion criteria
1.Colorectal cancer in past history
2.Infectious enteritis
3.Inframmatory bowel disease
4.Bowel obstruction
5.Other inappropriate patient
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | ISHIBE |
Organization
Yokohama City University
Division name
Gastroenterological surgery
Zip code
2360004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, KANAGAWA
TEL
045-787-2650
aishibe@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Atushi |
| Middle name | |
| Last name | ISHIBE |
Organization
Yokohama City University
Division name
Gastroenterological surgery
Zip code
2360004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, KANAGAWA
TEL
045-787-2650
Homepage URL
aishibe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University , Gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promation of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, KANAGAWA
Tel
045-370-7627
rinri@yokohama-cu.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
横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
港北肛門クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure the gas component from flatus of the subject at home for one week.
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040265
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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