NCT03732339

Brief Summary

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 24, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

October 8, 2018

Last Update Submit

April 23, 2022

Conditions

Locally Advanced Breast CancerCirculating Tumor Cell

Outcome Measures

Primary Outcomes (1)

  • Predictive value of CTC in ypT0 ypN0

    Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy

Secondary Outcomes (3)

  • Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR

    before and 22-28(±7) days after first dose of neoadjuvant chemotherapy

  • hypersensitivity

    up to 1 year

  • Detection rate of GILUPI CellCollector®

    before and 22-28(±7) days after first dose of neoadjuvant chemotherapy

Study Arms (1)

GILUPI CellCollector®

EXPERIMENTAL
Device: GILUPI CellCollector®

Interventions

GILUPI CellCollector®DEVICE

Use of GILUPI CellCollector® to detect CTC

GILUPI CellCollector®

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
  • ECOG 0-1
  • Adequate organ function
  • Consent to undergo CTC analysis in vivo

You may not qualify if:

  • Pregnant or breastfeeding patients
  • Metastatic or recurrent patients
  • Uncontrollable infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jinsong Lu

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Breast Surgery Department

Study Record Dates

First Submitted

October 8, 2018

First Posted

November 6, 2018

Study Start

August 24, 2018

Primary Completion

March 11, 2019

Study Completion

June 30, 2019

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

CN(1)