Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 6:59 PM
Study NCT ID:
NCT02904135
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2016-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
Sponsor:
MiCareo Taiwan Co., Ltd.
Organization:
Study Overview
Official Title:
Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-03
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:
To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: