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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025068
Receipt No. R000028834
Scientific Title Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Date of disclosure of the study information 2016/11/30
Last modified on 2016/11/30

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Basic information
Public title Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Acronym Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Scientific Title Assessment of additional value of a pit pattern diagnosis for the JNET Type2B lesions
Scientific Title:Acronym 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
1st name
Middle name
Last name Nobuya Mimori
Organization Hiraka General Hospital
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Nobuya Mimori
Organization Hiraka General Hospital
Division name Department of Gastroenterology
Zip code
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)

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
2016 Year 11 Month 30 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
2016 Year 06 Month 01 Day
Date of IRB
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

Other
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

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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