UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010832 |
|---|---|
| Receipt number | R000012613 |
| Scientific Title | Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/04/13 16:30:47 |
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Basic information
Public title
Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Acronym
SSA/P Study
Scientific Title
Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Scientific Title:Acronym
SSA/P Study
Region
| Japan |
Condition
Condition
SSA/P
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence of SSA/P in serrated lesions of the colorectum.
Basic objectives2
Others
Basic objectives -Others
To elucidate the incidence of SSA/P in serrated lesions of the colorectum.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of SSA/P in serrated lesions of the colorectum.
Key secondary outcomes
Macroscopic features and malignant potential of SSA/P.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 40 and over
Key exclusion criteria
Patients with a history of polypectomy for colorectal serrated polyps.
Patients with a history of colectomy or rectectomy.
Patients with inflammatory bowel disease.
Patients with a family history of colorectal polyposis or HNPCC.
Patients with colorectal polyposis or HNPCC.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Sano |
Organization
Sano hospital
Division name
Institute of Minimally-invasive Endoscopic Care (iMEC)
Zip code
Address
2-5-1, Shimizugaoka, Tarumi, Kobe, Hyogo, Japan
TEL
078-785-1000
watasano@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Sano |
Organization
Sano hospital
Division name
Institute of Minimally-invasive Endoscopic Care (iMEC)
Zip code
Address
2-5-1, Shimizugaoka, Tarumi, Kobe, Hyogo, Japan
TEL
078-785-1000
Homepage URL
watasano@yahoo.co.jp
Sponsor or person
Institute
Sano hospital
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
佐野病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0034-1391948
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 | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012613
