UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031303 |
|---|---|
| Receipt number | R000035730 |
| Scientific Title | Development of novel cytologic sampling device for cervical cancer screening |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2018/02/14 15:30:09 |
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Basic information
Public title
Development of novel cytologic sampling device for cervical cancer screening
Acronym
Development of novel cytologic sampling device for cervical cancer screening
Scientific Title
Development of novel cytologic sampling device for cervical cancer screening
Scientific Title:Acronym
Development of novel cytologic sampling device for cervical cancer screening
Region
| Japan |
Condition
Condition
Cervical cancer and cervical precursor lesion
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Currently, a number of sampling devices for cervical cancer screening are on the market. However, there is no optimal sampling device that can handle any situation so that various devices are used for each purpose and facility. We have developed a new brush for sampling device now. This examination aims to develop more suitable sampling device using the new brush.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse event at cell collection and measurement the amount of collected cells
Key secondary outcomes
Evaluate appropriateness of specimens and symptoms such as bleeding and pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Existing device(Cervex)/Existing device(Cervex)
Interventions/Control_2
New device/Existing device(Cervex)
Interventions/Control_3
New device/Existing device(cotton swab)
Interventions/Control_4
New device/Existing device(YUINO BRUSH)
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 aged 20 years or older, patients scheduled to undergo cervical cytology diagnosis, patients who obtained their consent by written document
Key exclusion criteria
Patients who doctor judged inappropriate for participation in this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shibata |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2309
tshibata@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shibata |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2309
Homepage URL
tshibata@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TEIBOW COMPANY
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Neuroceuticals
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
浜松医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035730
