UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033690 |
|---|---|
| Receipt number | R000038349 |
| Scientific Title | Usefulness of cold polypectomy using Linked color imaging |
| Date of disclosure of the study information | 2018/08/13 |
| Last modified on | 2020/02/10 17:33:32 |
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Basic information
Public title
Usefulness of cold polypectomy using Linked color imaging
Acronym
LCI-CSP study
Scientific Title
Usefulness of cold polypectomy using Linked color imaging
Scientific Title:Acronym
LCI-CSP study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of cold polypectomy using Linked color imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
remnant rate of adenoma after cold polypectomy
Key secondary outcomes
technical results, complication rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Biopsy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
colorectal polyp<10mm
adenoma
age over20,under85
PS0-1
agreement
Key exclusion criteria
bad general status
disagreement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Suzuki |
| Middle name | |
| Last name | Takuto |
Organization
Chiba cancer center
Division name
Division of endoscopy
Zip code
2608717
Address
666-2 Nitona-cho, Chuo-ku, Chiba city, Chiba
TEL
043-264-5431
taksuzuki@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba cancer center
Division name
Division of endoscopy
Zip code
2608717
Address
666-2 Nitona-cho, Chuo-ku, Chiba city, Chiba
TEL
0432645431
Homepage URL
taksuzuki@chiba-cc.jp
Sponsor or person
Institute
Chiba cancer center Division of endoscopy
Institute
Department
Personal name
Funding Source
Organization
Chiba cancer center, Division of endoscopy
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
Chiba Cancer center
Address
666-2Nitona-cho, Chuo-ku, Chiba city, Chiba
Tel
0432645431
taksuzuki@chiba-cc.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
千葉県がんセンター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038349
