UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019502 |
|---|---|
| Receipt number | 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 09:45:31 |
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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
| Obstetrics 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
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
naka44725@a2.keio.jp
Sponsor or person
Institute
The Japanese Society of Clinical Cytology
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
