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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004218
Receipt No. R000005069
Scientific Title Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study
Date of disclosure of the study information 2010/09/21
Last modified on 2013/10/02

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Basic information
Public title Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study
Acronym Feasibility study of ECS for esophageal squamous-cell carcinoma
Scientific Title Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study
Scientific Title:Acronym Feasibility study of ECS for esophageal squamous-cell carcinoma
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of ECS in the diagnosis of esophageal squamous-cell carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity : Comparison of the ECS images and corresponding histology
Key secondary outcomes 1) multi-rator k value in the pathologists
2) the proportion of high quality ECS images sufficient to evaluation
3) Specificity
4) multi-rator k value between the pathologists and endoscopists

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) superficial esophageal cancer larger than 10 mm in size and histologically confirmed as squamous-cell carcinoma or high grade intraepithelial neoplasia
2) Written informed consent
Key exclusion criteria 1) severe complication
2) having prior radiotherapy for the esophagus
3) having prior chemotherapy
4) contraindication for biopsy and endoscopic treatment
5) inadequate to entry considered by each investigator

Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507
TEL 075-751-4319
Email shuko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuko Morita
Organization Kyoto University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507
TEL 075-751-4319
Homepage URL
Email shuko@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization The Japanese Foundation For Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 09 Month 21 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
2010 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 07 Month 22 Day

Other
Other related information prospective study

Management information
Registered date
2010 Year 09 Month 15 Day
Last modified on
2013 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005069

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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