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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

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.

Condition or disease
Gastric Cancer

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources




Biospecimen Retention:   Samples Without DNA
plasma tears


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who receiving S-1 as an adjuvant chemotherapy after radial surgery for gastric cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621919


Contacts
Contact: Keon-Wook Lee, MD 82-31-787-7073 hmodocto@hanmail.net

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, GYeonggi-do, Korea, Republic of, 463-707
Contact: Keun-Wook Lee    82-31-787-7037      
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Keun-Wook Lee, MD Seoul National University Bundang Hospital

Responsible Party: Namju Kim, Professor for clinical department, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01621919     History of Changes
Other Study ID Numbers: TITAP
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases