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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033768
Receipt No. R000038519
Scientific Title A prospective observational study evaluating the efficacy of confocal laser endomicroscopy for the diagnosis of colorectal laterally spreading tumors.
Date of disclosure of the study information 2018/08/15
Last modified on 2020/05/15

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Basic information
Public title A prospective observational study evaluating the efficacy of confocal laser endomicroscopy for the diagnosis of colorectal laterally spreading tumors.
Acronym Efficacy of CLE for the diagnosis of colorectal LSTs
Scientific Title A prospective observational study evaluating the efficacy of confocal laser endomicroscopy for the diagnosis of colorectal laterally spreading tumors.
Scientific Title:Acronym Efficacy of CLE for the diagnosis of colorectal LSTs
Region
Japan

Condition
Condition colorectal laterally spreading tumors (LSTs)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the confocal laser endomicroscopy for the diagnosis of colorectal laterally spreading tumors, a prospective observational study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic rate (sensitivity/specificity)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with 20mm or larger colorectal LSTs.
Key exclusion criteria The patients with an allergy for fluorescein.
Patients in disagreement with informed consent
Others
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Sakai
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 2470005
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 08033828342
Email eiji525@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Sakai
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 2470005
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 08033828342
Homepage URL
Email eiji525@yokohama-cu.ac.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization NTT Medical Center Tokyo
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 NTT Medical Center Tokyo
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo
Tel 0334486111
Email eiji525@yokohama-cu.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
2018 Year 08 Month 15 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 40
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 15 Day
Date of IRB
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038519

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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