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NCT04968964 · ClinicalTrials.gov registry record · NA
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
A NA study of Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04968964 is a NA study of Breast Cancer and Cancer of the Breast that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 55 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04968964, a NA study of Breast Cancer and Cancer of the Breast, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.
Conditions Studied
Interventions
- DEVICE DiviTum® TKa assay
- OTHER Study Care Plans
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04968964
The ClinicalTrials.gov registry entry for NCT04968964 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which DiviTum® TKa assay is the first listed.
NCT04968964 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04968964 about?
NCT04968964 is a clinical study titled "Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing". Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a si...
What is the current status of trial NCT04968964?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2022-03-07. Estimated completion is 2029-09-30.
What conditions does trial NCT04968964 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer of the Breast.
What interventions are being tested in trial NCT04968964?
The interventions under investigation include: DiviTum® TKa assay (DEVICE), Study Care Plans (OTHER).
Who is sponsoring clinical trial NCT04968964?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04968964 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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