UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050303 |
|---|---|
| Receipt number | R000057261 |
| Scientific Title | Efficacy and Safety of Endoscopic Treatment for Patients with Serrated Polyposis Syndrome (SPS) |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/02/10 18:07:33 |
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Basic information
Public title
A Retrospective Study of the Feasibility and Safety of Endoscopic Control in Patients with Serrated Polyposis Syndrome
Acronym
A Retrospective Study of the Feasibility and Safety of Endoscopic Control in Patients with Serrated Polyposis Syndrome
Scientific Title
Efficacy and Safety of Endoscopic Treatment for Patients with Serrated Polyposis Syndrome (SPS)
Scientific Title:Acronym
Efficacy and Safety of Endoscopic Treatment for Patients with Serrated Polyposis Syndrome (SPS)
Region
| Japan |
Condition
Condition
Serrated Polyposis Syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively examine the feasibility and safety of endoscopic control in patients with Serrated Polyposis Syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The achievement rate of endoscopic control(EC) (achieving EC was defined as complete polyp removal (all polyps larger than 3 mm) accomplished by endoscopic treatment alone)
Key secondary outcomes
The endoscopic treatment combination used to achieve EC, treatment-related adverse events, and detection of advanced neoplasia (colorectal cancer, sessile serrated lesions with dysplasia and advanced adenoma, advanced serrated lesions) during the surveillance phase
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who fulfilled SPS diagnostic criteria defined by the World Health Organization (WHO) in 2019 in their fifth edition of the Classification of Tumors of the Digestive System
I) At least 5 serrated lesions/polyps proximal to the rectum, all 5 mm or more in size, with at least 2 being 10 mm or more in size
II) At least 20 serrated lesions/polyps of any size distributed throughout the large bowel, with at least 5 being proximal to the rectum
Key exclusion criteria
The patients with known inflammatory bowel disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Nakaoka |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL
+81-3-3775-3111
michiko_cinnamon@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Nakaoka |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL
+81-3-3775-3111
Homepage URL
michiko_cinnamon@ybb.ne.jp
Sponsor or person
Institute
Omori Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Omori Red Cross 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
Omori Red Cross Hospital
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
Tel
+81-3-3775-3111
michiko_cinnamon@ybb.ne.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
大森赤十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 10 | 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
43
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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To retrospectively examine the feasibility and safety of endoscopic control in patients with Serrated Polyposis Syndrome
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057261
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
