CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

NCT ID: NCT03732339

Last Updated: 2022-04-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Breast Cancer Circulating Tumor Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GILUPI CellCollector®

Group Type EXPERIMENTAL

GILUPI CellCollector®

Intervention Type DEVICE

Use of GILUPI CellCollector® to detect CTC

Interventions

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GILUPI CellCollector®

Use of GILUPI CellCollector® to detect CTC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnant or breastfeeding patients
* Metastatic or recurrent patients
* Uncontrollable infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Viroad Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jinsong Lu

Chief of Breast Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinsong Lu

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RenJiH-2018-038

Identifier Type: -

Identifier Source: org_study_id

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