UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019541
Receipt number R000022576
Scientific Title Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology
Date of disclosure of the study information 2016/04/01
Last modified on 2022/06/20 10:40:17

* 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

Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology

Acronym

Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology

Scientific Title

Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology

Scientific Title:Acronym

Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology

Region

Japan


Condition

Condition

infection

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of detection pre-processing method and the detection reagent that contribute to the infection diagnosis and treatment

Basic objectives2

Others

Basic objectives -Others

Reagent development

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The effectiveness of the pre-treatment method

Key secondary outcomes

The effectiveness of the nucleic acid detection reagents


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

In addition to the specimen collection in the normal inspection, to collect the specimen.1 subject once.

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

Department of Obstetrics and Gynecology outpatient visits

Key exclusion criteria

under 20

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Yasuhisa
Middle name
Last name Terao

Organization

Juntendo Univ.

Division name

Department of Obstetrics and Gynecology

Zip code

113-8421

Address

Tokyo Hongo, Bunkyo-ku, 2-1-1

TEL

03-3813-3111-3365

Email

yterao@juntendo.ac.jp


Public contact

Name of contact person

1st name Yasuhisa
Middle name
Last name Terao

Organization

Juntendo Univ.

Division name

Department of Obstetrics and Gynecology

Zip code

113-8421

Address

Tokyo Hongo, Bunkyo-ku, 2-1-1

TEL

03-3813-3111-3365

Homepage URL


Email

yterao@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Univ.Department of Obstetrics and Gynecology

Institute

Department

Personal name



Funding Source

Organization

Juntendo Univ.Department of Obstetrics and Gynecology

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

juntendo Hospital IRB

Address

Tokyo Hongo, Bunkyo-ku, 2-1-1

Tel

03-5802-1584

Email

kenkyu5858@juntendo.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

2016 Year 04 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


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

2015 Year 10 Month 23 Day

Date of IRB

2015 Year 10 Month 23 Day

Anticipated trial start date

2015 Year 10 Month 23 Day

Last follow-up date

2022 Year 06 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 28 Day

Last modified on

2022 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name