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

Circulating Tumor Cells.Breast Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006055
• Other study ID #: VIROAD01
• Status: Recruiting
• Phase: Phase 3
• First received: December 21, 2016
• Last updated: December 29, 2016
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Beijing Viroad Biotechnology Co., Ltd.
• Contact: YH Dong, MD
• Phone: +86031189928691
• Email: dongyh_viroad[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Circulating Tumor Cells.Breast
• Neoplastic Cells, Circulating

Intervention

Device:
• Circulating tumor cells

Locations

Country	Name	City	State
China	The 307th Hospital of Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Viroad Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of CellCollector	CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.	6 month	No
Primary	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.	6 month	No