Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Yale University.
NCT06572800 is a NA study that has completed, run by Yale University. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be estimated using the two-sided 95% exact confidence interval (CI) using Clopper-Pearson method.
Interventions
- DEVICE DiviTum-TKa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2025-09-16 |
| Phase | NA |
What the finished NCT06572800 record still lists
NCT06572800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which DiviTum-TKa is the first listed.
NCT06572800 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06572800's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI