UMIN-CTR Clinical Trial

Public title

Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases

Acronym

Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases

Scientific Title

Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases

Scientific Title:Acronym

Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases

Region

Japan

Condition

Infectious eye disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases

Basic objectives2

Others

Basic objectives -Others

Positive predictive value

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Positive predictive value

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients suspected of having t infectious eye disease, and also who gave us the agreement with the aim of this clinical trial.

Key exclusion criteria

Patients who is determined inappropriate to participate in the study by the attending physician

Target sample size

250

Name of lead principal investigator

1st name	(A) Norio Shimizu, (B) Sunao Sugita, (C) Hiroshi T
Middle name
Last name	(A) Norio Shimizu, (B) Sunao Sugita, (C) Hiroshi Takase, (D) Satoko Nakano

Organization

(A)(C) Tokyo Medical and Dental University
(B) RIKEN
(D) Oita University

Division name

(D) Department of Ophthalmology

Zip code

879-5593

Address

(D) 1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan

TEL

097-586-5904

Email

snakano-oph@umin.ac.jp

Name of contact person

1st name	Satoko
Middle name
Last name	Nakano

Organization

Oita University

Division name

Department of Ophthalmology

Zip code

879-5593

Address

1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan

TEL

097-586-5904

Homepage URL

Email

snakano-oph@umin.ac.jp

Institute

Tokyo Medical and Dental University
RIKEN
Oita University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Oita University

Address

1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan

Tel

097-586-6163

Email

gcrcjimu@oita-u.ac.jp>

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学(東京都) / Tokyo Medical and Dental University
理化学研究所(兵庫県) / RIKEN
大分大学(大分県) / Oita University
北海道大学(北海道) / Hokkaido University
北海道医療大学(北海道) / Health Sciences University of Hokkaido
東北大学(宮城県) / Tohoku University
群馬大学(群馬県) / Gunma University
東京大学(東京都) / The University of Tokyo
東京医科大学(東京都) / Tokyo Medical University
東邦大学医療センター大森病院(東京都) / Toho University Omori Medical Center
福井大学(福井県) / University of Fukui
京都府立医科大学(京都府) / Kyoto Prefectural University of Medicine
神戸市立神戸アイセンター病院 / Kobe Eye Center
山口大学(山口県) / Yamaguchi University
いしづち眼科(愛媛県) / Ishizuchi Eye Clnic
高知大学(高知県) / Kochi University
九州大学(福岡県) / Kyushu University
宮田眼科病院(宮崎県) / Miyata Ophthalmic Hospital
島津製作所(京都府)/ Shimadzu Corporation
Capital Medical University(Beijing, China)
Kresge Eye Institute(Detroit, Michigan, U.S.A)
University of Sao Paulo(Sao Paulo, Brazil)
Universite Paris Descartes(Paris, France)

Date of disclosure of the study information

2015

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2014

Year

06

Month

23

Day

Date of IRB

2015

Year

05

Month

26

Day

Anticipated trial start date

2014

Year

06

Month

23

Day

Last follow-up date

2023

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design:
Prospective study

Recruitment of Subject:
All patients who visit our institute since June 2014 and meet the inclusion/exclusion criteria .

Primary outcome:
Evaluation of comprehensive polymerase chain reaction system for infectious eye disease (Positive predictive value)

Registered date

2015

Year

11

Month

09

Day

Last modified on

2020

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022761