UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032138 |
|---|---|
| Receipt number | R000036276 |
| Scientific Title | Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2023/09/15 11:54:19 |
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Basic information
Public title
Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome
Acronym
Investigation for Serrated Polyposis Syndrome
Scientific Title
Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome
Scientific Title:Acronym
Investigation for Serrated Polyposis Syndrome
Region
| Japan |
Condition
Condition
serrated polyposis syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify clinicopathological features for serrated polypossyndrome
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinicopathological features for serrated polyposis syndrome
Key secondary outcomes
Detection rate for serrated polyposis syndrome
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
Patients with serrated polyposis syndrome patients from 15 institutes affiliated with the Gastroenterological Polyposis Study Group
Key exclusion criteria
underage
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
734-8551
Address
1-2-3, Kasumi Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5538
colon@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Urabe |
Organization
Hiroshima University Hospital
Division name
epartment of Regeneration and Medicine, Medical Center for translational and Clinical Research
Zip code
734-8551
Address
1-2-3, Kasumi Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5955
Homepage URL
beyan13@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Endoscopy
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital Department of Endoscopy
Address
1-2-3, Kasumi Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-5538
beyan13@hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
https://endosc.hiroshima-u.ac.jp
Publication of results
Published
Result
URL related to results and publications
https://endosc.hiroshima-u.ac.jp
Number of participants that the trial has enrolled
94
Results
Eighty-seven patients (92.6%) satisfied the WHO diagnostic criterion I and 16 (17.0%) criterion II. Nine patients (9.6%) simultaneously satisfied criteria I and II. Invasive carcinoma and advanced carcinoma was observed in 21 patients (22.3%), 24 lesions. Of the 21 patients with CRC, 20 patients (95.2%) satisfied diagnostic criterion I, 2 patient (9.5%) diagnostic criterion II, and 1 patient (4.8%) diagnostic criteria I and II.
Results date posted
| 2021 | Year | 04 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Preparation for submiting the paper
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 18 | Day |
Baseline Characteristics
A total of 94 patients were diagnosed with SPS at 10 institutes during a period from January 2001 until December 2017.
Participant flow
We investigated the clinicopathological characteristics in patients with SPS accumulated through the "Multicenter Study on clinicopathological characteristics of SPS (UMIN 000032138)" by the Colorectal Serrated Polyposis Syndrome (SPS) Study Group, which was donated by the Japanese Society of Gastroenterology (JSGE). In this study, we diagnosed patients with SPS according to 2019 World Health Organization (WHO) SPS diagnostic criteria.
Adverse events
None
Outcome measures
We investigated the clinicopathological characteristics in patients with SPS accumulated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 04 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036276
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/27 | ○研究計画書・プロトコール.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/27 | SPS2次調査アンケート（患者調査票）200407.xlsx |
