UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027192 |
|---|---|
| Receipt number | R000031160 |
| Scientific Title | Evaluation of eye disorder induced by chemotherapy including S-1 |
| Date of disclosure of the study information | 2017/06/24 |
| Last modified on | 2024/11/23 14:53:34 |
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Basic information
Public title
Evaluation of eye disorder induced by chemotherapy including S-1
Acronym
EyeDropS study(HGCSG1604)
Scientific Title
Evaluation of eye disorder induced by chemotherapy including S-1
Scientific Title:Acronym
EyeDropS study(HGCSG1604)
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted this prospective cohort study to confirm more precise analysis about S-1 induced Eye disorders incidence
Basic objectives2
Others
Basic objectives -Others
prospective cohort study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
cumulative incidence of epiphora in periods from start of S-1 chemotherapy to 12 weeks after induction S-1
Key secondary outcomes
cumulative incidence of epiphora in overall S-1 chemotherapy periods, the time of outbreak and severity of epiphora, the situation of ophthalmological intervention, ophthalmological changes, risk factors of epiphora, and QOL
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) Histologically confirmed carcinoma in GIC, including esophageal, gastric, colorectal, pancreatic, and biliary cancer.
2) Receives chemotherapy including S-1.
3) Age 20 years or older
4) Written informed consent.
Key exclusion criteria
1) Prior medication of S-1.
2) Continuing the eye drops treatment.
3) Scheduled to have an ophthalmic operation within six months.
4) Lachrymal duct obstruction or more than
three points of corner conjunctiva epithelium disorder score.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo, Japan
TEL
+81-11-716-1161
ykomatsu@ac.cyberhome.ne.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Yagisawa |
Organization
Hokkaido University Hospital
Division name
Cancer center
Zip code
060-8648
Address
Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo, Japan
TEL
+81-11-716-1161
Homepage URL
yagisawa.m@hotmail.co.jp
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Study Group: HGCSG
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2017 | Year | 06 | Month | 24 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Management information
Registered date
| 2017 | Year | 04 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031160
