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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031712
Receipt No. R000036211
Scientific Title Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors
Date of disclosure of the study information 2018/03/14
Last modified on 2019/03/29

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Basic information
Public title Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors
Acronym Endocytoscopic imaging of cervical and vaginal intraepithelial tumors
Scientific Title Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors
Scientific Title:Acronym Endocytoscopic imaging of cervical and vaginal intraepithelial tumors
Region
Japan

Condition
Condition cervical and vaginal intraepithelial tumors
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of endocytoscopy for diagnosis of cervical and vaginal intraepithelial tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic accuracy of endocytoscopic images to histological diagnosis from biopsy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic intervention is only one day of the examination date
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

Not applicable
Gender Female
Key inclusion criteria Patients who have intraepithelial tumors of ervical and vagina
Key exclusion criteria Patitents who have a history of allergy to methylene blue
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoko Ono
Organization Hokkaido University Hospital
Division name Divison of Endoscopy
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL 0117161161
Email onosho@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoko Ono
Organization Hokkaido University Hospital
Division name Divison of Endoscopy
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL 0117161161
Homepage URL
Email onosho@med.hokudai.ac.jp

Sponsor
Institute Divison of Endoscopy, Hokkaido University Hospital
Institute
Department

Funding Source
Organization Self funding
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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
2017 Year 03 Month 15 Day
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
2019 Year 03 Month 18 Day
Date of closure to data entry
2019 Year 03 Month 22 Day
Date trial data considered complete
2019 Year 03 Month 22 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036211

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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