UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011582
Receipt number R000013543
Scientific Title Sequence analysis of mitochondrial DNA in eye diseases
Date of disclosure of the study information 2013/08/26
Last modified on 2013/08/26 20:20:43

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Basic information

Public title

Sequence analysis of mitochondrial DNA in eye diseases

Acronym

Sequence analysis of mitochondrial DNA

Scientific Title

Sequence analysis of mitochondrial DNA in eye diseases

Scientific Title:Acronym

Sequence analysis of mitochondrial DNA

Region

Japan


Condition

Condition

mitochondrial disease, optic nerve disease, retinal degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate the association between the whole sequence of mitochondrial DNA and eye disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sequence of whole mitochondrial DNA in mitochondrial disease.

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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

mitochondrial disease, optic nerve disease, retinal degeneration

Key exclusion criteria

none

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagahisa Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-751-3248

Email

nagaeye@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Hata

Organization

Kyoto University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-751-3248

Homepage URL


Email

trj74h6@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2013 Year 08 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

Preinitiation

Date of protocol fixation

2013 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Total number of 500 people, until March 31th, 2018.


Management information

Registered date

2013 Year 08 Month 26 Day

Last modified on

2013 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013543


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name