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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001623
Receipt No. R000001952
Scientific Title Utility of Narrow band imaging(NBI) colposcopy
Date of disclosure of the study information 2009/01/07
Last modified on 2016/10/19

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Basic information
Public title Utility of Narrow band imaging(NBI) colposcopy
Acronym NBI colposcopy
Scientific Title Utility of Narrow band imaging(NBI) colposcopy
Scientific Title:Acronym NBI colposcopy
Region
Japan

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

Objectives
Narrative objectives1 to investigate NBI colposcopy utility
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes accuracy of the tests
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 Female
Key inclusion criteria cervical neoplasia
Key exclusion criteria postmenopausal
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Fujii
Organization Keio University, School of Medicine
Division name obstetrics and gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku,Tokyo,Japan
TEL 03-3353-1211
Email fujiit44@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Fujii
Organization Keio University, School of Medicine
Division name obstetrics and gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku,Tokyo,Japan
TEL 03-3353-1211
Homepage URL
Email fujiit44@gmail.com

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Grand-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor olympus medical systems
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
2009 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2008 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective,
case control study

Management information
Registered date
2009 Year 01 Month 07 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001952

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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