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NCT03860376 · ClinicalTrials.gov registry record
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
A clinical trial, sponsored by Florida International University.
- Completed
- Registry status
- 25
- Enrollment target
NCT03860376: Completed study, sponsored by Florida International University.
NCT03860376 is a clinical trial that has completed, run by Florida International University. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860376 has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing (DST). In addition, genetic information will be obtained from cancer and normal (germline) tissue and correlated with drug response. This study will provide the platform for informing treating physician about individualized treatment options. The main outcome of this study will be the proportions of the patients whose treatment was guided by the personalized medicine approach.
Primary Outcome
This study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a monotherapy or combination drug regimen based on functional and/or genomics data within 4 weeks in at least 16 out of 25 patients (64%). To achieve at least 90% power, the null hypothesis will be rejected when at least 16 out of 25 patients receive treatment recommendations through functional and/or genomics data within 4 weeks on the study. With that outcome, we would have 95% confid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2022-12-31 |
What the finished NCT03860376 record still lists
NCT03860376 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03860376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03860376 about?
NCT03860376 is a clinical study titled "Ex Vivo Drug Sensitivity Testing and Mutation Profiling". This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing (DST). In addition, genetic information will be obtained from cancer and nor...
What is the current status of trial NCT03860376?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2019-02-21. Estimated completion is 2022-12-31.
Who is sponsoring clinical trial NCT03860376?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
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