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
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Sponsor:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Namju Kim, Seoul National University Bundang Hospital
Tracking Information | ||||
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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 |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: plasma tears
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Seoul National University Bundang Hospital | |||
Verification Date | June 2012 |