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NCT04561453 · ClinicalTrials.gov registry record
Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer
A clinical trial, sponsored by University of Washington.
- Terminated
- Registry status
- 14
- Enrollment target
NCT04561453: Clinical Trial study, sponsored by University of Washington.
NCT04561453 is a clinical trial that was terminated before completion, run by University of Washington. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04561453 was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- 14 participants
- Enrollment target
Study Summary
This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months p
Primary Outcome
The investigators will measure the percentage of patients for whom organoids are able to be successfully cultured and subjected to a drug screen.
Interventions
- DIAGNOSTIC_TEST Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2025-04-04 |
Why NCT04561453 stopped before completion
NCT04561453 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring is the first listed.
NCT04561453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04561453 about?
NCT04561453 is a clinical study titled "Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer". This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make deci...
What is the current status of trial NCT04561453?
This trial is currently terminated. The enrollment target is 14 participants. The study started on 2020-07-08. Estimated completion is 2025-04-04.
What interventions are being tested in trial NCT04561453?
The interventions under investigation include: Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04561453?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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