CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

NCT ID: NCT05360290

Last Updated: 2025-09-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2029-06-30

Brief Summary

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The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.

Detailed Description

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Conditions

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Breast Cancer Circulating Tumor Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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CTC positive

Group Type ACTIVE_COMPARATOR

GILUPI CellCollector®

Intervention Type DEVICE

Use of GILUPI CellCollector® to detect CTC

CTC negative

Group Type OTHER

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

* Female, aged ≥18 and ≤70 years;
* Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment);
* Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
* Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
* ECOG 0-1

Exclusion Criteria

* Metastatic disease (Stage IV);
* Female patients who are pregnancy or lactation;
* Uncontrollable puncture site infection or systemic infection;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wenjin Yin

Deputy Chief of Breast Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenji Yin

Role: CONTACT

86(21)68385569

Qi Lu

Role: CONTACT

86(21)68383364

Facility Contacts

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Jinsong Lu, MD

Role: primary

Other Identifiers

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KY2022-044-B

Identifier Type: -

Identifier Source: org_study_id

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