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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033690
Receipt No. 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

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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
Email 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
Email taksuzuki@chiba-cc.jp

Sponsor
Institute Chiba cancer center Division of endoscopy
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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