Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1
1 other identifier
observational
200
1 country
1
Brief Summary
S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 18, 2012
June 1, 2012
2 years
June 14, 2012
June 14, 2012
Conditions
Eligibility Criteria
Patients who receiving S-1 as an adjuvant chemotherapy after radial surgery for gastric cancer
You may qualify if:
- Patients who received radical surgery for gastric cancer
- Patients who receiving S-1 adjuvant chemotherapy
- Patients who administrated S-1 for more than 7 days
You may not qualify if:
- who using eyedrop medication
- who has dry eye that tear cannot be sampled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Biospecimen
plasma tears
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Keun-Wook Lee, MD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor for clinical department
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
June 18, 2012
Record last verified: 2012-06