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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036190
Receipt No. R000033451
Scientific Title Prospective study on the efficacy of HPV testing for cervical screening in Japan: JCHO multicenter study
Date of disclosure of the study information 2019/04/01
Last modified on 2020/05/04

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Basic information
Public title Prospective study on the efficacy of HPV testing for cervical screening in Japan: JCHO multicenter study
Acronym JCHO-HPV
Scientific Title Prospective study on the efficacy of HPV testing for cervical screening in Japan: JCHO multicenter study
Scientific Title:Acronym JCHO-HPV
Region
Japan

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

Objectives
Narrative objectives1 To assess the best population-based cervical cancer screening protocol to evaluate appropriate target ages, screening intervals and cost-effectiveness for the Japanese population.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of HPV-based cervical cancer screening strategy
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

Not applicable
Gender Female
Key inclusion criteria All participants who visit the Japan Community Health Care Organisation (JCHO) hospitals.

1) Population-based screening
2) Age 20 years old at the primary screening
3) consent for the study
4)Screening is performed by target methods
Key exclusion criteria If participants show any intention to disagree with the study, they will be excluded from a subject of study.
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Kouichi
Middle name
Last name Hashimoto
Organization Tokyo Yamate medical center, the Japan Community Health Care Organisation (JCHO) hospital
Division name Obstetrics and Gynecology
Zip code 169-0073
Address Hyakunin-cho 3-22-1, Shinjuku-ku, Tokyo, Japan
TEL 03-3364-0251
Email sakamaki-ken@yamate.jcho.go.jp

Public contact
Name of contact person
1st name Yutarou
Middle name
Last name Fujimori
Organization The Japan Community Health Care Organisation (JCHO)
Division name Policy planning division
Zip code 108-8583
Address Takanawa 3-22-12, Minato-ku, Tokyo, Japan
TEL 03-3445-0862
Homepage URL
Email iryoka@jcho.go.jp

Sponsor
Institute The Japan Community Health Care Organisation (JCHO)
Institute
Department

Funding Source
Organization The Japan Community Health Care Organisation (JCHO)
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 National Hospital Organization Institutional Review Board
Address Higashigaoka 2-5-1, Meguro-ku, Tokyo
Tel 03-3411-0111
Email crsc@kankakuki.go.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
2019 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 04 Day
Date of IRB
2017 Year 09 Month 04 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 05 Month 31 Day
Date trial data considered complete
2023 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033451

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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