UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019502
Receipt No. R000022540
Scientific Title The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing
Date of disclosure of the study information 2015/11/18
Last modified on 2020/05/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing
Acronym The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing
Scientific Title The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing
Scientific Title:Acronym The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing
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 evaluate the clinical utility of new test by LC1000(exfoliative cell analyzer) for cervical cancer testing by comparison with HPV testing in the approximately 1 year follow-up.
Basic objectives2 Others
Basic objectives -Others To compare the standard cervical cytology with the result of LC-1000analyzer.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Difference of the Accuracy (Sensitivity for the "Disease case" defined as CIN2 or worse) and Specificity for the "Non-Disease case" defined as the case that dysplasia is not confirmed in this study period ) between the new test by LC-1000 analyzer and HPV test.
Key secondary outcomes Accuracy (Sensitivity and Specificity) between LC-1000 test and cytology for the detection of CIN2 or worse.

Accuracy (Sensitivity and Specificity) between LC-1000 test and other test (combination or alone test by cytology, HPV test) for the detection of CIN3 or worse.

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
70 years-old >
Gender Female
Key inclusion criteria (1)Women whom close examination is required
Women who diagnosed ASC-US or worse within 24 weeks, or suspected cervical abnormalities in past clinical findings
Women who can cooperate the specimen collection
Women who provided informed consent

(2)Women for the pap smear (1st screening test)
Women who provided informed
Key exclusion criteria Women who have had cervical invasive cancer before.
Women who have underwent cervical conization or hysterectomy before.
Pregnant women
Women judged ineligible for this study by investigator.
Target sample size 930

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki
Organization Keio University, School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo,160-8582, Japan
TEL 03-3353-1211
Email aoki@z7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Nakamura
Organization Keio University, School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo,160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email naka44725@a2.keio.jp

Sponsor
Institute The Japanese Society of Clinical Cytology
Institute
Department

Funding Source
Organization Sysmex corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Diagnostic Pathology, Kumamoto University Hospital
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 慶應義塾大学医学部附属病院(東京都) 
公益財団法人 大阪がん循環器病予防センター(大阪府)
公益財団法人 東京都予防医学協会(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 18 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
2015 Year 06 Month 30 Day
Date of IRB
2015 Year 09 Month 25 Day
Anticipated trial start date
2015 Year 10 Month 15 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information Case control study

Women who come to our hospital and meet the key inclusion criteria

To measureCPIx as a cellular proliferative potential by LC-1000 analyzer.

Management information
Registered date
2015 Year 10 Month 26 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.