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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035342
Receipt No. 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 2019/06/26

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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
Email 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
Email aishibe@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University , Gastroenterological surgery
Institute
Department

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
Email 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
2021 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
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040265

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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