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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031665
Receipt No. R000036167
Scientific Title Development of colposcopy application
Date of disclosure of the study information 2018/03/11
Last modified on 2019/03/11

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Basic information
Public title Development of colposcopy application
Acronym Development of colposcopy application
Scientific Title Development of colposcopy application
Scientific Title:Acronym Development of colposcopy application
Region
Japan

Condition
Condition uterine cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To improve diagnostic accuracy by colposcopy, we develop software(application) which helps gynecologist's diagnosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic concordance rate of gynecologist's colposcopy findings and computer findings
Key secondary outcomes diagnostic concordance rate of biopsy and computer findings

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 Female
Key inclusion criteria Patient who needs biopsy under colposcopy and agrees to entry on this study
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Noriomi
Middle name
Last name Matsumura
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 589-8511
Address 377-2,Ono-higashi,Osakasayama,Osaka,Japan
TEL 072-366-0221
Email noriomi@med.kindai.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Murakami
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 589-8511
Address 377-2,Ono-higashi,Osakasayama,Osaka,Japan
TEL 072-366-0221
Homepage URL
Email kmurakami@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization None
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 Kindai University Faculty of Medicine IRB
Address 377-2,Ono-higashi,Osakasayama,Osaka,Japan
Tel 072-366-0221
Email zizen@med.kindai.ac.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
2018 Year 03 Month 11 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
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 11 Month 13 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 03 Month 10 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036167

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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