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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name