Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2010-11-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been reported from some case and small-sized studies. The incidence of developing LDO has been estimated to about 15\~20% of patients receiving S-1 therapy in some retrospective studies. However, there is no prospective report on the incidence of LDO in patients receiving S-1 chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.
Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will be explored. These results will help clinicians identify patients who are at high risk of developing S-1-associated LDO.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GC patients receiving adjuvant S-1 chemotherapy
S-1
Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
S-1
Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients receiving adjuvant S-1 chemotherapy
* Patients with adequate major organ functions for chemotherapy
* Patient who have taken S-1 at least 7 days (for blood and tear sampling)
Exclusion Criteria
* Patients with previous history of LDO
* Patients with other opthalmologic disease who are not appropriate to be included in this study (i.e., patients using eyedrop medication; patients with dry eye whose tears cannot be sampled)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Bundang Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Keun-Wook Lee
Clinical professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keun-Wook Lee, M.D. & Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Seoul National University Bundang Hospital
Namju Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Opthalmology, Seoul National University Bundang Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Keun-Wook Lee Lee, M.D. & Ph.D.
Role: primary
Namju Kim, M.D.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GC-CTX-01
Identifier Type: OTHER
Identifier Source: secondary_id
GC-SNUBH-2010-01
Identifier Type: -
Identifier Source: org_study_id