UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027137
Receipt number R000031097
Scientific Title Prospective study of the exploration of bioactive lipid biomarker involved in ocular diseases
Date of disclosure of the study information 2017/04/26
Last modified on 2021/04/29 10:09:11

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Basic information

Public title

Prospective study of the exploration of bioactive lipid biomarker involved in ocular diseases

Acronym

Prospective exploration of bioactive lipid biomarker involved in ocular diseases

Scientific Title

Prospective study of the exploration of bioactive lipid biomarker involved in ocular diseases

Scientific Title:Acronym

Prospective exploration of bioactive lipid biomarker involved in ocular diseases

Region

Japan


Condition

Condition

glaucoma, uveitis, AMD, vitreoretinal disease, dry eye, cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

measurement of lipid mediators and proteins in aqueous humor, vitreous and tears.

Basic objectives2

Others

Basic objectives -Others

quantitative evaluation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between clinical parameters.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with indication for surgery

Key exclusion criteria

subjects without consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Aihara

Organization

The University of Tokyo

Division name

Department of Ophthalmology

Zip code

1138655

Address

7-3-1, Hongo

TEL

0338155411

Email

aihara-tky@umin.ac.jp


Public contact

Name of contact person

1st name Megumi
Middle name
Last name Honjo

Organization

The University of Tokyo

Division name

Department of Ophthalmology

Zip code

1138655

Address

7-3-1, Hongo

TEL

0338155411

Homepage URL


Email

mhonjo-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo

Address

7-3-1, Hongo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2017 Year 04 Month 26 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

Open public recruiting

Date of protocol fixation

2015 Year 10 Month 26 Day

Date of IRB

2015 Year 10 Month 26 Day

Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2026 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observation


Management information

Registered date

2017 Year 04 Month 26 Day

Last modified on

2021 Year 04 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031097


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name