UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective analysis of eye disorders induced by chemotherapy including S-1 for Gastrointestinal cancer.
Title of the study (Brief title)	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	Masataka Yagisawa
Organization	Sapporo City General Hospital
Division name	Department of Gastroenterology
Address	1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL	080-1104-6869
Email	yagisawa.m@hotmail.co.jp

Public contact
Name of contact person	Masataka Yagisawa
Organization	Sapporo City General Hospital
Division name	medical office
Address	1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL	011-726-2211
Homepage URL
Email	yagisawa.m@hotmail.co.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027820