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

December 29, 2016 updated by: Beijing Viroad Biotechnology Co., Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • The 307th Hospital of Chinese People's Liberation Army
        • Contact:
          • ZF Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBC Group
metastatic breast cancer Age：18-75 ECOG:0-2
Device: Circulating tumor cells
Experimental: Control Group
benign breast tumour Age：18-75 ECOG:0-2
Device: Circulating tumor cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Viroad Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 26, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIROAD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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