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NCT06572800 · ClinicalTrials.gov registry record · NA
Tka Assay for CDK4/6i
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT06572800 is a NA study that has completed, run by Yale University. The registered enrollment target is 34 participants.
The verdict
NCT06572800, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.
Interventions
- DEVICE DiviTum-TKa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2025-09-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06572800
The ClinicalTrials.gov registry entry for NCT06572800 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DiviTum-TKa is the first listed.
NCT06572800 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06572800 about?
NCT06572800 is a clinical study titled "Tka Assay for CDK4/6i". This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progeste...
What is the current status of trial NCT06572800?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2023-09-05. Estimated completion is 2025-09-16.
What interventions are being tested in trial NCT06572800?
The interventions under investigation include: DiviTum-TKa (DEVICE).
Who is sponsoring clinical trial NCT06572800?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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