UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031665 |
|---|---|
| Receipt number | R000036167 |
| Scientific Title | Development of colposcopy application |
| Date of disclosure of the study information | 2018/03/11 |
| Last modified on | 2024/09/13 13:51:18 |
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Basic information
Public title
Development of colposcopy application
Acronym
Development of colposcopy application
Scientific Title
Development of colposcopy application
Scientific Title:Acronym
Development of colposcopy application
Region
| Japan |
Condition
Condition
uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To improve diagnostic accuracy by colposcopy, we develop software(application) which helps gynecologist's diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic concordance rate of gynecologist's colposcopy findings and computer findings
Key secondary outcomes
diagnostic concordance rate of biopsy and computer findings
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patient who needs biopsy under colposcopy and agrees to entry on this study
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriomi |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
589-8511
Address
377-2,Ono-higashi,Osakasayama,Osaka,Japan
TEL
072-366-0221
noriomi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Murakami |
Organization
Kindai University Faculty of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
589-8511
Address
377-2,Ono-higashi,Osakasayama,Osaka,Japan
TEL
072-366-0221
Homepage URL
kmurakami@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kindai University Faculty of Medicine IRB
Address
377-2,Ono-higashi,Osakasayama,Osaka,Japan
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
| 2018 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.med.kindai.ac.jp/rinri/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/13/9/1596
Number of participants that the trial has enrolled
40
Results
It was confirmed that accuracy, precision, and F1 scores, which were 0.894, 0.837, and 0.834, respectively, were significantly better when images taken before and after acetic acid solution application were used than when only images taken after acetic acid solution application were used (0.882, 0.823, and 0.823, respectively).
Results date posted
| 2024 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the patients who underwent colposcopy for abnormal cervical cytology, we selected those for whom the images taken before and after acetic acid solution application were available.
Participant flow
For the colposcopy procedure in this study, first, the discharge was removed thoroughly, the cervix was observed with a colposcope (OLYMPUS Corp., Shinjuku, Tokyo, Japan), and the photograph was taken with a digital camera (E-PL5, OLYMPUS Corp., Shinjuku, Tokyo, Japan) connected to the scope with an exposure time between 1/100 and 1/40 s and an ISO sensitivity of 400. Next, a cotton ball soaked in 3% acetic acid solution was pressed against the cervix and left for 1 min. Then, the cotton ball was removed, the cervix was observed briefly (30 s) with a colposcope, and the photograph was taken again in the same manner. The focus was adjusted manually. The colposcopy was performed on all the patients by a gynecologic oncologist with more than ten years of experience.
Adverse events
none
Outcome measures
In this method, to segment the lesion effectively, the colposcopic images taken before acetic acid solution application were input to the deep learning network, U-Net, for lesion segmentation with the images taken following acetic acid solution application. We conducted experiments using 30 actual colposcopic images of acetowhite epithelium, one of the representative types of CIN.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036167
