Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1

• ClinicalTrials.gov Identifier: NCT01621919
• Recruitment Status: Unknown
• First Posted: June 18, 2012
• Last Update Posted: June 18, 2012
• Sponsor: Seoul National University Bundang Hospital
• Information provided by (Responsible Party): Namju Kim, Seoul National University Bundang Hospital

Tracking Information

• First Submitted Date: June 14, 2012
• First Posted Date: June 18, 2012
• Last Update Posted Date: June 18, 2012
• Study Start Date: December 2010
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1
• Official Title: Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy
• 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.

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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

plasma tears

• Sampling Method: Probability Sample
• Study Population: Patients who receiving S-1 as an adjuvant chemotherapy after radial surgery for gastric cancer
• Condition: Gastric Cancer
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 14, 2012): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2013
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• who using eyedrop medication
• who has dry eye that tear cannot be sampled

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01621919
• Other Study ID Numbers: TITAP
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Namju Kim, Seoul National University Bundang Hospital
• Study Sponsor: Seoul National University Bundang Hospital
• Collaborators: Not Provided

Investigators

• Study Director: Keun-Wook Lee, MD; Seoul National University Bundang Hospital

• PRS Account: Seoul National University Bundang Hospital
• Verification Date: June 2012