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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039970
Receipt No. R000045572
Scientific Title Usefulness of HPV genotyping after cervical conization in patients with cervical intraepithelial neoplasia
Date of disclosure of the study information 2020/04/01
Last modified on 2020/11/06

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Basic information
Public title Usefulness of HPV genotyping after cervical conization in patients with cervical intraepithelial neoplasia
Acronym HPV genotyping after conization
Scientific Title Usefulness of HPV genotyping after cervical conization in patients with cervical intraepithelial neoplasia
Scientific Title:Acronym HPV genotyping after conization
Region
Japan

Condition
Condition Cervical intraepithelial neoplasia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the relationship between CIN2+ recurrence rate and high-risk HPV infection before and after cervical conization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence rate by HPV genotyping test result before and after cervical conization
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
75 years-old >=
Gender Female
Key inclusion criteria Histologically confirmed CIN2 or 3
Conization for the first time
Key exclusion criteria Expecting women
Obvious invasive cancer
Target sample size 150

Research contact person
Name of lead principal investigator
1st name TAKAHIRO
Middle name
Last name KOYANAGI
Organization Jichi Medical University
Division name Depertment of Obstetrics and Gynecology
Zip code 329-0431
Address 3311-1 Yakushiji, Shimotsuke City, Tochigi, Japan
TEL 0285587376
Email koyataka@snow.plala.or.jp

Public contact
Name of contact person
1st name TAKAHIRO
Middle name
Last name KOYANAGI
Organization Jichi Medical University
Division name Research Support Section
Zip code 329-0431
Address 3311-1 Yakushiji, Shimotsuke City, Tochigi, Japan
TEL 0285587550
Homepage URL
Email rinri@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Japan BD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jichi Medical University
Address 3311-1 Yakushiji, Shimotsuke City, Tochigi, Japan
Tel 0285587550
Email rinri@jichi.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
2020 Year 04 Month 01 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
2019 Year 08 Month 05 Day
Date of IRB
2019 Year 08 Month 05 Day
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No noteworthy items.

Management information
Registered date
2020 Year 03 Month 29 Day
Last modified on
2020 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045572

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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