UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051655 |
|---|---|
| Receipt number | R000058944 |
| Scientific Title | Prospective cohort study for serrated polyposis syndrome |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/20 00:47:10 |
* 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
prospective cohort study for serrated polyposis syndrome
Acronym
prospective cohort study for SPS
Scientific Title
Prospective cohort study for serrated polyposis syndrome
Scientific Title:Acronym
prospective cohort study for SPS
Region
| Japan |
Condition
Condition
Serrated polyposis syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively enroll cases of serrated polyposis syndrome (SPS) in Japan, and to obtain an overall picture of SPS, as well as to explore the clinical features of SPS, especially familial SPS with a high possibility of being hereditary.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
History of serous adenomatous patients, lifestyle, family history, information on treatment for colorectal tumors and colorectal cancer at the time of enrollment, history of testing for germline variants
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
SPS patient more than 18 years
Key exclusion criteria
Cases in which research consent was not obtained
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology
Zip code
734-8553
Address
1-2-3, Kasumi, Hiroshima
TEL
082-257-5190
oka4683@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Urabe |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology
Zip code
734-8553
Address
1-2-3, Kasumi, Hiroshima
TEL
082-257-5193
Homepage URL
beyan13@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Hereditary Tumors
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3, Kasumi, Hiroshima
Tel
082-257-1505
iryo-seisaku@office.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
| 2023 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2043 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The history, lifestyle, family history, information on treatment for colorectal tumors and colorectal cancer at the time of enrollment, and history of testing for germline variants will be recorded for eligible patients. However, personal information of family members will not be obtained.
In addition, the following medical information of eligible patients will be collected (detailed case report form)
1) ID number and initials of each facility
2) Age (date of birth)
3) Gender
4) Previous medical history (malignancies other than colorectal cancer)
5) Family history (SPS, colorectal cancer, malignancies other than colorectal cancer)
6) Life history (alcohol consumption, smoking)
7) Applicable WHO diagnostic criteria
8) Clinicopathological characteristics of previously treated colorectal tumors/colorectal cancer (localization, tumor size, number, treatment, histological type)
9) Clinicopathological characteristics (localization, tumor diameter, number, treatment, histological type) of colorectal tumors/colorectal cancer treated at the time of registration
10) History and results of genetic testing
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
