Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01621919
Status:
UNKNOWN
Last Update Posted:
2012-06-18
First Post:
2012-06-14
Brief Title:
Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 obstructionLDOcaused by S-1Suggested 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
Detailed Description:
1 S-1 metabolites concentration in plasma
1 factors affecting plasma concentration
surgery subtype
serum creatinine
2 systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration
enteritis
fatigue
2 S-1 metabolites concentration in tears
1 correlation of tear concentration with plasma concentration
2 lacrimal drainage obstruction caused by S-1 administration and its correlation with tear S-1 metabolites concentration
3 lacrimal drainage obstruction caused by S-1 administration and its correlation with plasma S-1 metabolites concentration
1 factors affecting plasma concentration
surgery subtype
serum creatinine
2 systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration
enteritis
fatigue
2 S-1 metabolites concentration in tears
1 correlation of tear concentration with plasma concentration
2 lacrimal drainage obstruction caused by S-1 administration and its correlation with tear S-1 metabolites concentration
3 lacrimal drainage obstruction caused by S-1 administration and its correlation with plasma S-1 metabolites concentration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None