UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047305 |
|---|---|
| Receipt number | R000053948 |
| Scientific Title | Clinical research on the usefulness of LC-1000 (detached cell analyzer) as a diagnostic support system for cervical cancer |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/02/04 06:42:46 |
* 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
Clinical research on the usefulness of LC-1000 (detached cell analyzer) as a diagnostic support system for cervical cancer
Acronym
Clinical research on the usefulness of LC-1000
Scientific Title
Clinical research on the usefulness of LC-1000 (detached cell analyzer) as a diagnostic support system for cervical cancer
Scientific Title:Acronym
Clinical research on the usefulness of LC-1000
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An Exploratory Study to Assess the Clinical Utility of LC-1000 Rank Classification Results as Diagnostic Support Information in Follow-up of Cervical Intraepithelial neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of LC-1000 Rank Classification Results with HPV Genotyping Results for Risk of Cervical Intraepithelial Tumor Progression
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 cytological abnormalities of ASC-US or higher
Key exclusion criteria
Those who could not give consent.
Those who have had invasive cervical cancer in the past.
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoki |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
aoki@z7.keio.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Nakamura |
Organization
Fujita Health University
Division name
Advanced Robotic and Endoscopic Surgery
Zip code
4771192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake,Aichi, Japan
TEL
0562932111
Homepage URL
masaru.nakamura@fujita-hu.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Sysmex corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
0333531211
ocr@crea.hosp.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20190252
Org. issuing International ID_1
Keio University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | 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
139
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
| 2019 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053948
