Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03427450
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2018-01-31
Brief Title:
Harvest of CTCs From MBC Patients Using the Parsortix PC1 System
Sponsor:
Angle plc
Organization:
Angle plc
Study Overview
Official Title:
Harvest of Circulating Tumor Cells CTCs From Patients With Metastatic Breast Cancer MBC Using the Parsortix PC1 System
Status:
COMPLETED
Status Verified Date:
2023-06
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:
HOMING
Brief Summary:
The purpose of this clinical study is to demonstrate that the Parsortix PC1 system enables the capture and harvest of circulating tumor cells CTCs from the peripheral blood of patients with metastatic breast cancer MBC and not from healthy volunteers HVs The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations eg cytopathology FISH qPCR RNAseq etc
This is an investigational study The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only
This is an investigational study The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only
Detailed Description:
Approximately 200 evaluable MBC patients either newly diagnosed or patients with progressiverecurrent disease who are about to start a new line of therapy for the treatment of their disease and 200 evaluable healthy volunteer HV subjects healthy women with no history of cancer will be enrolled at a minimum of three 3 US based clinical sites Each subject will have information about their age raceethnicity height and weight menopausal status smoking status pregnancy andor nursing status and a brief medical history captured at the time of enrollment Blood will be drawn from each subject into three different EDTA tubes minimum of 7mL up to a maximum of 23mL of whole blood specifically for the purposes of this study One of the blood tubes collected will be used for a complete blood count CBC with differential testing while the other two tubes of blood will be processed on the Parsortix PC1 system for the capture and harvest of CTCs The cells harvested from one of the blood tubes will be deposited onto a glass slide and automated Wright-Giemsa staining will be done to allow for identification of CTCs based on their cytologic features eg size shape nuclear to cytoplasmic ratio chromatin structure etc by an expert cytopathologist The cells harvested from the remaining blood tube will be used for one of three different evaluations Fluorescence in-situ hybridization FISH for evaluation of Her-2neu gene amplification quantitative reverse-transcriptase real-time PCR qRT-PCR for evaluation of cancer related gene expression or whole transcriptome sequencing RNAseq for determination of the expression patterns of breast cancer related genes
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