UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013997
Receipt number R000016309
Scientific Title Prospective multi center observational study for ocular side-effects by TS-1
Date of disclosure of the study information 2014/05/19
Last modified on 2019/11/22 09:15:14

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Basic information

Public title

Prospective multi center observational study for ocular side-effects by TS-1

Acronym

ocular side-effects by TS-1

Scientific Title

Prospective multi center observational study for ocular side-effects by TS-1

Scientific Title:Acronym

ocular side-effects by TS-1

Region

Japan


Condition

Condition

Ocular side-effects by TS-1

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the occurrence frequency, time, and condition and risk factor for the ocular sid-effects by TS-1

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

The occurrence frequency, time, and condition of the ocular sid-effects by TS-1

Key secondary outcomes

The risk factor for the ocular sid-effects by TS-1


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

1) The subject who have initial treatment of TS-1
2) The suject who is able to be obteined informed concent

Key exclusion criteria

1) The subject who have onstructive lacrimal system or active
ocular surface disease.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yuichji
Middle name
Last name Ohashi

Organization

Ehime University Graduated School of Medicine

Division name

Ophthalmology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime

TEL

089-960-5361

Email

ohashi@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Shiraishi

Organization

Ehime University Graduated School of Medicine

Division name

Ophthalmology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime

TEL

089-960-5361

Homepage URL


Email

shiraia@m.ehime-u.ac.jp


Sponsor or person

Institute

Japanese Society of Lacrimal Passage and Tear Dynamics
Japan Cornea Society

Institute

Department

Personal name



Funding Source

Organization

Japanese Society of Lacrimal Passage and Tear Dynamics
Japan Cornea Society

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

Ehime University Hospital

Address

Shitsukawa, Toon, Ehime

Tel

089-960-5172

Email

rinri@m.ehime-u.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

2014 Year 05 Month 19 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

202

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

No longer recruiting

Date of protocol fixation

2013 Year 05 Month 19 Day

Date of IRB

2014 Year 03 Month 24 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The progress will be reported.


Management information

Registered date

2014 Year 05 Month 19 Day

Last modified on

2019 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name