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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009686
Receipt No. R000011297
Scientific Title A study to find out appropriate observation/treatment of CIN
Date of disclosure of the study information 2013/01/07
Last modified on 2020/01/10

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Basic information
Public title A study to find out appropriate observation/treatment of CIN
Acronym CIN study
Scientific Title A study to find out appropriate observation/treatment of CIN
Scientific Title:Acronym CIN study
Region
Japan

Condition
Condition CIN 1, CIN 2
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out appropriate observation/treatment of CIN
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a possibility of progression to invasive carcinoma after every 6 months' follow-up
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 cytology, HPV typing and biopsy every 6 months
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 *CIN 1, 2 histologically diagnosed within 1 month before registration
*written informed consent
*equal to or older than 20 y
Key exclusion criteria *no CIN or CIN3+
*Serious complications (heart disease, uncontrolled diabetes mellitus, malignant hypertension and tendency to bleeding)
*past history of CIN
*pregnant women
*Patients judged inappropriate for this study by the physicians
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Ueda
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Email ZVF03563@nifty.ne.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Ueda
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Homepage URL
Email ZVF03563@nifty.ne.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine
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 Osaka University Hospital IRB
Address 2-2 Yamadaoka, Suita
Tel 06-6879-5411
Email rinri@hp-crc.med.osaka-u.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
2013 Year 01 Month 07 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
2012 Year 08 Month 24 Day
Date of IRB
2012 Year 10 Month 04 Day
Anticipated trial start date
2012 Year 10 Month 05 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 04 Day
Last modified on
2020 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011297

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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