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

NCT ID: NCT03006055

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Circulating Tumor Cells.Breast

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MBC Group

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

Group Type EXPERIMENTAL

Circulating tumor cells

Intervention Type DEVICE

Control Group

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

Group Type EXPERIMENTAL

Circulating tumor cells

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Circulating tumor cells

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Viroad Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

YH Dong, MD

Role: CONTACT

+86031189928691

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ZF Jiang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VIROAD01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.