UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056252 |
|---|---|
| Receipt number | R000064266 |
| Scientific Title | A cohort study on the short- and long-term treatment outcomes of underwater endoscopic resection for colorectal tumors |
| Date of disclosure of the study information | 2024/11/23 |
| Last modified on | 2024/11/23 16:14:08 |
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Basic information
Public title
A cohort study on the short- and long-term treatment outcomes of underwater endoscopic resection for colorectal tumors
Acronym
CURE-Colon Study
Scientific Title
A cohort study on the short- and long-term treatment outcomes of underwater endoscopic resection for colorectal tumors
Scientific Title:Acronym
CURE-Colon Study
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment outcomes of a novel endoscopic resection method, underwater mucosal resection, with conventional methods for colorectal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of positive histological resection margins, en bloc resection rate, frequency of post-treatment complications, and post-treatment local recurrence rate.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Endoscopic mucosal resection cases for colorectal tumors (underwater resection and conventional methods) performed at our institution from November 2018 to October 2024.
Key exclusion criteria
Not applicable.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Gastroenterology
Zip code
969-3492
Address
21-2 Maeda, Tanisama, Kawahigashi-machi, Aizuwakamatsu City, Fukushima Prefecture, Japan
TEL
0242752100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakajima |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Gastroenterology
Zip code
969-3492
Address
21-2 Maeda, Tanisama, Kawahigashi-machi, Aizuwakamatsu City, Fukushima Prefecture, Japan
TEL
0242752100
Homepage URL
naka1008@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Fukushima Medical University Ethics Review Committee
Address
1Hikariga-oka, Fukushima City, JAPAN
Tel
0245471825
fmu@esct.bvits.com
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
| 2024 | Year | 11 | Month | 23 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multivariate analysis using logistic regression will be performed on up to 10 factors that showed p<0.1 in univariate analysis.
Management information
Registered date
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064266
