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NCT04655573 · ClinicalTrials.gov registry record
A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer
A clinical trial, sponsored by Duke University.
- Terminated
- Registry status
- 7
- Enrollment target
NCT04655573: Clinical Trial study, sponsored by Duke University.
NCT04655573 is a clinical trial that was terminated before completion, run by Duke University. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655573 was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the feasibility of generating patient derived micro-organospheres (PDMO) from patients with advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.
Primary Outcome
The PDMO establishment will be monitored and success will be defined as the formation of 3D organoid structures in at least 80% of droplets in each well, in 20 randomly sampled wells per PDMO model, within 7 days. With an anticipated generation of 90% we anticipate being able to generate 13 PDMO from the first 15 patients to perform a drug screen within 10 days of biopsy. The exact 90% lower confidence bound (LCB) will be computed for the proportion of patients with successful generation of PDMO
Interventions
- PROCEDURE Breast Cancer Tumor Resection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2024-05-07 |
Why NCT04655573 stopped before completion
NCT04655573 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Breast Cancer Tumor Resection is the first listed.
NCT04655573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04655573 about?
NCT04655573 is a clinical study titled "A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer". The purpose of this study is to assess the feasibility of generating patient derived micro-organospheres (PDMO) from patients with advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.
What is the current status of trial NCT04655573?
This trial is currently terminated. The enrollment target is 7 participants. The study started on 2022-04-07. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT04655573?
The interventions under investigation include: Breast Cancer Tumor Resection (PROCEDURE).
Who is sponsoring clinical trial NCT04655573?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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