Back to resultsThe Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
Primary Purpose
Circulating Tumor Cells.Breast
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Circulating tumor cells
Sponsored by
About this trial
This is an interventional trial for Circulating Tumor Cells.Breast
Eligibility Criteria
Inclusion Criteria:
- Metastasis breast cancer confirmed with imaging examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Exclusion Criteria:
- Non-metastasis breast cancer
Sites / Locations
- The 307th Hospital of Chinese People's Liberation ArmyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MBC Group
Control Group
Arm Description
metastatic breast cancer Age：18-75 ECOG:0-2
benign breast tumour Age：18-75 ECOG:0-2
Outcomes
Primary Outcome Measures
Validation of CellCollector
CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
Secondary Outcome Measures
Full Information
NCT ID
NCT03006055
First Posted
December 21, 2016
Last Updated
December 29, 2016
Sponsor
Beijing Viroad Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03006055
Brief Title
The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Viroad Biotechnology Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor Cells.Breast
7. Study Design
Study Phase
Phase 3
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBC Group
Arm Type
Experimental
Arm Description
metastatic breast cancer Age：18-75 ECOG:0-2
Arm Title
Control Group
Arm Type
Experimental
Arm Description
benign breast tumour Age：18-75 ECOG:0-2
Intervention Type
Device
Intervention Name(s)
Circulating tumor cells
Primary Outcome Measure Information:
Title
Validation of CellCollector
Description
CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Time Frame
6 month
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastasis breast cancer confirmed with imaging examination
Have agreed to undergo CTC analysis in vivo;
ECOG：0-2
Exclusion Criteria:
Non-metastasis breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YH Dong, MD
Phone
+86031189928691
Email
dongyh_viroad@163.com
Facility Information:
Facility Name
The 307th Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZF Jiang
12. IPD Sharing Statement
Learn more about this trial
The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
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