UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010569 |
|---|---|
| Receipt number | R000012263 |
| Scientific Title | A study of human intestinal spirochetosis for association with the development of serrated lesion in colorectum |
| Date of disclosure of the study information | 2013/04/24 |
| Last modified on | 2015/12/09 13:05:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of human intestinal spirochetosis for association with the development of serrated lesion in colorectum
Acronym
A study of human intestinal spirochetosis for association with the development of serrated lesion in colorectum
Scientific Title
A study of human intestinal spirochetosis for association with the development of serrated lesion in colorectum
Scientific Title:Acronym
A study of human intestinal spirochetosis for association with the development of serrated lesion in colorectum
Region
| Japan |
Condition
Condition
sessile serrated adenoma/ polyp (SSA/P)
Classification by specialty
| Gastroenterology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the prevalence of HIS in SSA/P
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of HIS
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Sessile serrated lesions in colonrectum over 10mm endoscopically removed at our hospital and affiliated institutions during the period between January 2003 and December 2012.
Key exclusion criteria
Cases evaluated ineligible by principal investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido university hospital
Division name
Division of endoscopy
Zip code
Address
Kita 14 jo nishi 5 chome Kitaku Sapporo city Hokkaido
TEL
01117161161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Mabe |
Organization
Hokkaido university hospital
Division name
Division of endoscopy
Zip code
Address
Kita 14 jo nishi 5 chome Kitaku Sapporo city Hokkaido
TEL
0117161161
Homepage URL
katsumabe@me.com
Sponsor or person
Institute
Division of endoscopy, Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Division of endoscopy, Hokkaido university hospital
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
| 2013 | Year | 04 | Month | 24 | 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
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compare the spirochetosis infection rate of SSA/P group with control.
Management information
Registered date
| 2013 | Year | 04 | Month | 23 | Day |
Last modified on
| 2015 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012263
