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

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ClinicalTrials.gov Identifier: NCT01621919
Recruitment Status : Unknown
Verified June 2012 by Namju Kim, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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