UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016228 |
|---|---|
| Receipt number | R000018155 |
| Scientific Title | Changes of intestinal bacterial flora in colon carcinogenesis |
| Date of disclosure of the study information | 2015/12/11 |
| Last modified on | 2019/03/13 22:33:35 |
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Basic information
Public title
Changes of intestinal bacterial flora in colon carcinogenesis
Acronym
Changes of intestinal bacterial flora in colon carcinogenesis
Scientific Title
Changes of intestinal bacterial flora in colon carcinogenesis
Scientific Title:Acronym
Changes of intestinal bacterial flora in colon carcinogenesis
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference of bacterial flora between colon cancer, adenoma and nomal mucosa in patietns with colon cancer.
Basic objectives2
Others
Basic objectives -Others
To isolate the bacteria which is significantly rich in cancer lesion
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of bacterial flora between colon cancer, adenoma and nomal mucosa
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient present with colorectal cancer
subject without colorectal tumor as controls
Key exclusion criteria
1 patient with inflammatory bowel disease or any other disease of bowel inflammation
2 history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
3 history of abnormal blood clotting
4 risk of complication of biopsy due to antiplatelet drug or anticoanrants
5 patients who we can not get written informed consent from
6 patients judged as being inappropriate candidates for the trial by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama city university school of medicine
Division name
Gastroenterology and Hepatorogy
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
umezawa-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Gastroenterology and Hepatorogy
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Gastroenterology and Hepatorogy
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
81-45-787-2640
takuma_h@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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 11 | 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
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective
case-control sampling
Management information
Registered date
| 2015 | Year | 01 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018155
