UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043670 |
|---|---|
| Receipt number | R000049866 |
| Scientific Title | How to manage the colorectal high-grade dysplasia or cancer resected by cold snare polypectomy: Multicenter exploratory study |
| Date of disclosure of the study information | 2021/03/19 |
| Last modified on | 2024/03/21 11:20:30 |
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Basic information
Public title
How to manage the colorectal high-grade dysplasia or cancer resected by cold snare polypectomy: Multicenter exploratory study
Acronym
How to manage the colorectal high-grade dysplasia or cancer resected by cold snare polypectomy: Multicenter exploratory study
Scientific Title
How to manage the colorectal high-grade dysplasia or cancer resected by cold snare polypectomy: Multicenter exploratory study
Scientific Title:Acronym
How to manage the colorectal high-grade dysplasia or cancer resected by cold snare polypectomy: Multicenter exploratory study
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical course and surveillance methods for colorectal cancers or high-grade dysplasias that were resected by cold snare polypectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The local recurrence rate after cold snare polypectomy for colorectal cancers or dysplasias
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients who underwent at least 1-time surveillance colonoscopy after cold snare polypectomy for colorectal cancers or dysplasias from January 2010 to August 2020.
2)The data of patients who underwent cold snare polypectomy by August 2019 were used to investigate the local recurrence after a year.
3)The data of patients who underwent cold snare polypectomy by August 2017 were used to investigate the local recurrence after three years.
Key exclusion criteria
1) The patients who showed interest in opt-out for the present study
2) The patients with the possibility of contamination by a concomitant advanced colorectal cancer
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Inoki |
Organization
Department of Medicine, Showa University School of Medicine
Division name
Division of Gastroenterology
Zip code
142-8666
Address
1-5-8, Hatanodai
TEL
0337848535
kinoki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Inoki |
Organization
Department of Medicine, Showa University School of Medicine
Division name
Division of Gastroenterology
Zip code
142-8666
Address
1-5-8, Hatanodai
TEL
0337848535
Homepage URL
kinoki@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Medicine, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine, Showa University School of Medicine
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
Showa University Research Administration Center
Address
Hatanodai, Shinagwa-ku, 1-5-8
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2021 | Year | 03 | Month | 19 | 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
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study for colorectal cancer resected by cold snare polypectomy
Management information
Registered date
| 2021 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049866
