The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device

Beijing Viroad Biotechnology

Status and phase: Unknown; Phase 3

Conditions: Circulating Tumor Cells.Breast

Treatments: Device: Circulating tumor cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT03006055

VIROAD01

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

190 participants in 2 patient groups

MBC Group

Experimental group

Description:

metastatic breast cancer Age：18-75 ECOG:0-2

Treatment:

Device: Circulating tumor cells

Control Group

Experimental group

Description:

benign breast tumour Age：18-75 ECOG:0-2

Treatment:

Device: Circulating tumor cells