Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04968964
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2021-07-08
Brief Title:
Treatment Monitoring of Patients Receiving CDK 46 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
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
TK IMPACT Treatment Monitoring of Patients Receiving CDK 46 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 Physician Decision Impact Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None