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NCT02055560 · ClinicalTrials.gov registry record
Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients
A clinical trial, sponsored by Saladax Biomedical.
- Completed
- Registry status
- 146
- Enrollment target
NCT02055560: Completed study, sponsored by Saladax Biomedical.
NCT02055560 is a clinical trial that has completed, run by Saladax Biomedical. The registered enrollment target is 146 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02055560 has completed, sponsored by Saladax Biomedical.
- COMPLETED
- Registry status
- 146 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.
Primary Outcome
At each treatment cycle (i.e. Cycle 1, Cycle 2, Cycle 3, etc.), we will plot the 5-FU exposure (i.e. AUC value) and determine the average, median, standard deviation, and percent coefficient of variation (%CV). These statistics will also be determined for all 5-FU exposure values combined.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-12-18 |
What the finished NCT02055560 record still lists
NCT02055560 is an observational study that tracks outcomes without assigning an intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02055560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02055560 about?
NCT02055560 is a clinical study titled "Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients". The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to character...
What is the current status of trial NCT02055560?
This trial is currently completed. The enrollment target is 146 participants. The study started on 2014-01. Estimated completion is 2015-12-18.
Who is sponsoring clinical trial NCT02055560?
This trial is sponsored by Saladax Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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