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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Namju Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01621919
First received: June 14, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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
Gastric Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Biospecimen Retention:   Samples Without DNA

plasma tears


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 14, 2012
Last Updated: June 14, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014