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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004529
Receipt No. R000005378
Scientific Title Accuracy of endoscopy and histology in diagnosing superficial esophageal cancer.
Date of disclosure of the study information 2010/11/09
Last modified on 2013/04/26

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Basic information
Public title Accuracy of endoscopy and histology in diagnosing superficial esophageal cancer.
Acronym Optical biopsy of esophageal cancer.
Scientific Title Accuracy of endoscopy and histology in diagnosing superficial esophageal cancer.
Scientific Title:Acronym Optical biopsy of esophageal cancer.
Region
Japan

Condition
Condition Superficial esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of diagnostic accuracy between endoscopy and histology on superficial esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of endoscopic diagnosis and histologic diagnosis
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

Not applicable
Gender Male and Female
Key inclusion criteria Superficial esophageal cancer diagnosed by endoscopy or biopsy.
Patients who will undergo endoscopic resection or surgical resection.
Patients with written informed consent.
Key exclusion criteria Patients with past history of operation, chemotherapy or radiotherapy for esophageal cancer.
Patients who have been judged as inappropriate for this study.
Patients with esophageal lesion, which will not be resected.
Patients with allergy to iodine.
Patients with esophageal lesion in the area of reflux esophagitis.
Patients with esophageal lesion 5mm or less.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi,Higashinari-ku,Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi,Higashinari-ku,Osaka
TEL
Homepage URL
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
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
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 11 Month 09 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
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 04 Month 26 Day
Date of closure to data entry
2013 Year 04 Month 26 Day
Date trial data considered complete
2013 Year 04 Month 26 Day
Date analysis concluded
2013 Year 04 Month 26 Day

Other
Other related information Comparison of endoscopic diagnosis and histologic diagnosis.
Histological diagnosis of endoscopic or surgical resected specimen is served as reference standard.

Management information
Registered date
2010 Year 11 Month 09 Day
Last modified on
2013 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005378

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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