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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002243
Receipt No. R000002746
Scientific Title Perinuclear halo observed in uterine cervical cytology.
Date of disclosure of the study information 2009/07/27
Last modified on 2010/07/24

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Basic information
Public title Perinuclear halo observed in uterine cervical cytology.
Acronym Perinuclear halo observed in uterine cervical cytology.
Scientific Title Perinuclear halo observed in uterine cervical cytology.
Scientific Title:Acronym Perinuclear halo observed in uterine cervical cytology.
Region
Japan

Condition
Condition Cervical intraepithelial neoplasia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Strict comparison between koilocytosis caused by human papilloma virus and inflammatory perinuclear halo on gynecologic cytological smear using in situ hybridization technique.
Basic objectives2 Others
Basic objectives -Others Confirmation of human papilloma virus infection on cells, which were judged as infection on Papanicolaou stained cytological smear.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Existence of human papilloma viral DNA in cells with perinuclear halo observed on Papanicolaou stained cytological smear.
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 Patients with uterine cervical inttraepithelial neoplasia followed up in gynecological outpatient clinic of Teikyo University Hospital.
Key exclusion criteria None.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiko Tanaka
Organization Teikyo University
Division name Dept.of Medical Technology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo 173-8605
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Teikyo University
Division name Dept.of Medical Technology
Zip code
Address
TEL 03-3964-1211
Homepage URL
Email ftanaka@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 27 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
2009 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case study of cytological smear obtained from outpatients with human papilloma virus related uterine cervical intraepithelial neoplasia in order to compare Papanicolaou staining and in situ hybridization technique.

Management information
Registered date
2009 Year 07 Month 23 Day
Last modified on
2010 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002746

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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