UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024160 |
|---|---|
| Receipt number | R000027820 |
| Scientific Title | A retrospective analysis of eye disorders induced by chemotherapy including S-1 for Gastrointestinal cancer. |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2016/09/26 00:50:11 |
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Basic information
Public title
A retrospective analysis of eye disorders induced by chemotherapy including S-1 for Gastrointestinal cancer.
Acronym
REyeDropS
Scientific Title
A retrospective analysis of eye disorders induced by chemotherapy including S-1 for Gastrointestinal cancer.
Scientific Title:Acronym
REyeDropS
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is conduct to determine the frequency and clinical characteristics of eye disorders induced by chemotherapy including S-1 for Gastrointestinal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of eye disorders
Key secondary outcomes
The time to onset and outcome of eye disorders and outcome
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients administered S-1 chemotherapy for gastrointestinal cancer in periods from January, 2008 to May, 2015 at Sapporo City General Hospital
Key exclusion criteria
The case that the dosage situation and side effect information of S-1 cannot confirm from a medical record enough
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Yagisawa |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL
080-1104-6869
yagisawa.m@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Yagisawa |
Organization
Sapporo City General Hospital
Division name
medical office
Zip code
Address
1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL
011-726-2211
Homepage URL
yagisawa.m@hotmail.co.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo City General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2016 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
