UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the accuracy of diagnosis by simple scoring system for SNADET
Acronym	Evaluation of the accuracy of diagnosis by simple scoring system for SNADET
Scientific Title	Evaluation of the accuracy of diagnosis by simple scoring system for SNADET
Scientific Title:Acronym	Evaluation of the accuracy of diagnosis by simple scoring system for SNADET
Region	Japan

Condition
Condition	superficial non-ampullary duodenal epithelial tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the diagnosis for SNADET by Simple scoring system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity, specificity, accuracy of the simple scoring system. Endoscopic diagnosis was performed before endoscopic treatment(ER). Endoscopic diagnosis using SSS was compared with pathological diagnosis after ER.
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 scheduled for endoscopic treatment for SNADET at our hospital
Key exclusion criteria	Pathological diagnosis after endoscopic treatment was not adenoma or cancer. Endoscopic diagnosis using simple scoring system was not performed.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Rindo Middle name Last name Ishii
Organization	NTT Medical Center Tokyo
Division name	Department of Gastrointestinal Endoscopy
Zip code	141-8625
Address	5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo
TEL	03-3448-6111
Email	rindokaben@yahoo.co.jp

Public contact
Name of contact person	1st name Rindo Middle name Last name Ishii
Organization	NTT Medical Center Tokyo
Division name	Department of Gastrointestinal Endoscopy
Zip code	141-8625
Address	5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo
TEL	03-3448-6111
Homepage URL
Email	rindokaben@yahoo.co.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	03-3448-6111
Email	rindokaben@yahoo.co.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	2022 Year 02 Month 28 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2029 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is the prospective study. We examined the diagnostic accuracy of the simple scoring system for the SNADET.

Management information
Registered date	2022 Year 02 Month 28 Day
Last modified on	2022 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053666