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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011496
Receipt No. R000013448
Scientific Title A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions
Date of disclosure of the study information 2013/08/19
Last modified on 2014/08/05

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Basic information
Public title A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions
Acronym A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions
Scientific Title A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions
Scientific Title:Acronym A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions
Region
Japan

Condition
Condition cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the diagnostic performance between conventional cytology and LBC for detecting the cervical lesions among women with abnormal cytology of ASC-US or worse.
Basic objectives2 Others
Basic objectives -Others performance comparison
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference in diagnostic accuracy between conventional cytology and LBC to detect the cervical lesions of CIN2 or worse with the cutoff level of ASC-US or worse.
Key secondary outcomes 1) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN2 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
2) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN1 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
3) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN3 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
4) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN2 or worse by conventional cytology and LBC with the cutoff value of LSIL or worse.
5) The agreement between conventional cytology and LBC.
6) The frequency of unsatisfactory specimens with conventional cytology and LBC.

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
30 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1)Women aged 30-64 years old.
2)Women with abnormal cytology with ASC-US or worse within 24 weeks following informed consent.
3)Participants provided written informed consent.
Key exclusion criteria 1)Women who have had prior cervical invasive cancer.
2)Women who have undergone cervical conization.
3)Women who have undergone hysterectomy.
4)Women who are pregnant.
5)Women are judged ineligible for this trial by physician.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
TEL 03-3353-1211(62391)
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
TEL
Homepage URL
Email

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Japanese Society of Clinical Cytology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2013 Year 08 Month 19 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 Completed
Date of protocol fixation
2013 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 19 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to compare the diagnostic performance between conventional cytology and LBC for detecting the cervical lesions among women with abnormal cytology of ASC-US or worse.

Management information
Registered date
2013 Year 08 Month 15 Day
Last modified on
2014 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013448

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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