UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Title of the study (Brief title)	Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Region	Japan

Condition
Condition	pharyngolaryngeal epithelial tumor, epithelial tumor of digestive tract, inflammatory bowel disease
Classification by specialty	Gastroenterology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic agreement between diagnosis by endocytoscopy and pathological diagnosis by biopsy, endoscopic resection and operation.
Key secondary outcomes	Diagnostic ability for tumor and inflammatory bowel disease by endocytoscopy (sensitivity, specificity, positive predictive value, and negative predictive value), Diagnostic ability of depth of invasion of tumor (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value)

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo an endoscopy with endocytoscopy
Key exclusion criteria	Patients who did not obtain consent
Target sample size	130

Research contact person
Name of lead principal investigator	Takeshi Yamamura
Organization	Nagoya university hospital
Division name	Department of Endoscopy
Address	65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL	0527412172
Email	tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masaya Esaki
Organization	Nagoya university hospital
Division name	Department of Endoscopy
Address	65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL	0527412172
Homepage URL
Email	em6089@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Endoscopy, Nagoya university hospital
Institute
Department

Funding Source
Organization	Department of Endoscopy, Nagoya university hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 07 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 10 Day
Anticipated trial start date	2018 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods

Management information
Registered date	2018 Year 07 Month 02 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037861