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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03006055
Enrollment
190
Registered
2016-12-30
Start date
2016-04-30
Completion date
2016-12-31
Last updated
2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells.Breast

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.

Interventions

DEVICECirculating tumor cells

Sponsors

Beijing Viroad Biotechnology Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validation of CellCollector6 monthCTC 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]6 monthNumber of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.

Countries

China

Contacts

Primary ContactYH Dong, MD
dongyh_viroad@163.com+86031189928691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026