UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of novel cytologic sampling device for cervical cancer screening
Title of the study (Brief title)	Development of novel cytologic sampling device for cervical cancer screening
Region	Japan

Condition
Condition	Cervical cancer and cervical precursor lesion
Classification by specialty	Obsterics 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	Toshiaki Shibata
Organization	Hamamatsu University School of Medicine
Division name	Obstetrics and gynecology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL	053-435-2309
Email	tshibata@hama-med.ac.jp

Public contact
Name of contact person	Toshiaki Shibata
Organization	Hamamatsu University School of Medicine
Division name	Obstetrics and gynecology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL	053-435-2309
Homepage URL
Email	tshibata@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035730