UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040971
Receipt number R000046772
Scientific Title Multicenter study Ophthalmology biobank
Date of disclosure of the study information 2020/07/02
Last modified on 2022/02/24 12:32:57

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Basic information

Public title

Multicenter study Ophthalmology biobank

Acronym

Multicenter study Ophthalmology biobank

Scientific Title

Multicenter study Ophthalmology biobank

Scientific Title:Acronym

Multicenter study Ophthalmology biobank

Region

Japan


Condition

Condition

All eye diseases

Classification by specialty

Ophthalmology Adult Child

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Tohoku University Hospital Ophthalmology and collaborative research institutes target patients with biological samples (excessive organs and tissues excised by blood, surgery, biopsy, and puncture) and patients Bank, manage and store information. Even when it is not necessary to collect a sample due to medical examination, blood/urine, feces, saliva, and oral plaque are collected from the patient. With comprehensive consent, the stored biological sample will be subjected to various analyzes including gene analysis based on the research plan applied and approved by the Ethics Committee in the future. By integrating the analysis results of biological samples and clinical information of individual patients, it is possible to conduct more meaningful research and contribute to the future development of medicine.

Basic objectives2

Others

Basic objectives -Others

Others

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

None

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

From March 2020 (after approval of the Ethics Review Committee) to February 2025, all patients who will visit Tohoku University Hospital Ophthalmology and joint research institutions will be targeted. Also, those who have been given consent and provided as ancillary research in the previous research.

Key exclusion criteria

Patients without consent

Target sample size

50000


Research contact person

Name of lead principal investigator

1st name Yu
Middle name
Last name Yokoyama

Organization

Tohoku University Hospital

Division name

Department of Ophthalmology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7294

Email

yu-yokoyama@oph.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Yokoyama

Organization

Tohoku University Hospital

Division name

Department of Ophthalmology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7294

Homepage URL


Email

yu-yokoyama@oph.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Graduate School of Medicine Ethics Committee

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-3867

Email

med-kenkyo@grp.tohoku.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

2020 Year 07 Month 02 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

2020 Year 06 Month 22 Day

Date of IRB

2020 Year 06 Month 22 Day

Anticipated trial start date

2020 Year 07 Month 02 Day

Last follow-up date

2025 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 07 Month 01 Day

Last modified on

2022 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name