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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Beijing Viroad Biotechnology Co., Ltd.

Current Primary Outcome:

• Validation of CellCollector [ Time Frame: 6 month ]
  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] [ Time Frame: 6 month ]
  Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.

Original Primary Outcome:

• Validation of CellCollector [ Time Frame: 6 month ]
  CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
• safety of CellCollector [ Time Frame: 6 month ]
  Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Beijing Viroad Biotechnology Co., Ltd.

Dates:
Date Received: December 21, 2016
Date Started: April 2016
Date Completion: December 2016
Last Updated: December 29, 2016
Last Verified: December 2016