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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027192
Receipt No. 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 2022/05/09

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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
Email 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
Email yagisawa.m@hotmail.co.jp

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group: HGCSG
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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