UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039970 |
|---|---|
| Receipt number | 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 | 2023/10/02 07:18:45 |
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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
| Obstetrics 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
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
rinri@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
No longer 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
| 2026 | 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
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045572
| 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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| Registered date | File name |
