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
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
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
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
