UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Title of the study (Brief title)	Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Region	Japan

Condition
Condition	colon cancer
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Whether additional pit pattern diagnosis improoves historogical acuracy of Type 2B lesions assessed in predicting a histological HGD/SM-s carcinoma?
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The sensitivity, specificity, positive predictive value, negative predictive, and accuracy of Type2B lesions The sensitivity, specificity, positive predictive value, negative predictive, and accuracy of Additional pit pattern diagnosis in Type2B lesions
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	We evaluated the consecutive cases treated by endoscopic resection in Hiraka General Hospital.
Key exclusion criteria	none
Target sample size	300

Research contact person
Name of lead principal investigator	Nobuya Mimori
Organization	Hiraka General Hospital
Division name	Department of Gastroenterology
Address	Hiraka General Hospital 3-1 Yatukuchi, Maego, Yokote City, Akita, Japan, 013-0013
TEL	0182325121
Email	riderboo@violet.plala.or.jp

Public contact
Name of contact person	Nobuya Mimori
Organization	Hiraka General Hospital
Division name	Department of Gastroenterology
Address	Hiraka General Hospital 3-1 Yatukuchi, Maego, Yokote City, Akita, Japan, 013-0013
TEL	0182325121
Homepage URL
Email	riderboo@violet.plala.or.jp

Sponsor
Institute	Hiraka General Hospital
Institute
Department

Funding Source
Organization	Hiraka General 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	2016 Year 11 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 30 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	Type 2B were examined by the additional pit pattern diagnosis and assessed in predicting a histological HGD/SM-s carcinoma.

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028834