NCT03006055

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 21, 2016

Last Update Submit

December 29, 2016

Conditions

Circulating Tumor Cells.Breast

Outcome Measures

Primary Outcomes (2)

  • Validation of CellCollector

    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]

    Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.

    6 month

Study Arms (2)

MBC Group

EXPERIMENTAL

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

Device: Circulating tumor cells

Control Group

EXPERIMENTAL

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

Device: Circulating tumor cells

Interventions

Circulating tumor cellsDEVICE
Control GroupMBC Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastasis breast cancer confirmed with imaging examination
  • Have agreed to undergo CTC analysis in vivo;
  • ECOG：0-2

You may not qualify if:

  • Non-metastasis breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

RECRUITING

Central Study Contacts

YH Dong, MD

CONTACT

+86031189928691dongyh_viroad@163.com

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 30, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12

Locations

CN(1)