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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024483
Receipt No. R000028162
Scientific Title Non randomized single-arm study of cervical partial resection and diathermy for CIN
Date of disclosure of the study information 2016/11/01
Last modified on 2017/07/03

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Basic information
Public title Non randomized single-arm study of cervical partial resection and diathermy for CIN
Acronym diathermy for CIN
Scientific Title Non randomized single-arm study of cervical partial resection and diathermy for CIN
Scientific Title:Acronym diathermy for CIN
Region
Japan

Condition
Condition CIN2/3
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy and safety of local treatment of uterine cervix
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes recurrence of the disease in 24 months
Key secondary outcomes 1.efficacy of HPV testing for reccurrence
2.monitoring adverse effects

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 operation, once
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
50 years-old >=
Gender Female
Key inclusion criteria 1.patients obtained documents of fully informed consent
2.patients aged from 20 to 50.
3.diagnosed with CIN2/3
4.disease area is not occupied in whole cervix
5. PS 0 or 1
6.no past history of cone, vapolization or hysterectomy
Key exclusion criteria 1.impossible conservative observation due to severe complication
2.no active double cancer
3.psychic disorder
4.pregnant
5.inadequate condition judged by doctors
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Fujii
Organization Fujita Health University
Division name Department of Obstetrics and Gynecology
Zip code
Address Kutsukakecho,Toyoake, Aichi
TEL 0562-93-2111
Email fujiit44@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Fujii
Organization Fujita Health University
Division name department of Obstetrics and Gynecology
Zip code
Address Kutsukakecho, Toyoake, Aichi
TEL 0562-93-9294
Homepage URL
Email fujiit44@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
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 藤田保健衛生大学(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 01 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028162

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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