UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036190 |
|---|---|
| Receipt number | 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 | 2021/09/13 11:30:43 |
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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
| Obstetrics 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
sakamaki-ken@yamate.jcho.go.jp
Public contact
Name of contact person
| 1st name | Shunki |
| Middle name | |
| Last name | Itou |
Organization
The Japan Community Health Care Organisation (JCHO)
Division name
Medical Economics Division
Zip code
108-8583
Address
Takanawa 3-22-12, Minato-ku, Tokyo, Japan
TEL
03-3445-0862
Homepage URL
iryoka@jcho.go.jp
Sponsor or person
Institute
The Japan Community Health Care Organisation (JCHO)
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033451
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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