RecruitingNot ApplicableNCT05360290

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

The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial


Sponsor

RenJi Hospital

Enrollment

484 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria3

  • Metastatic disease (Stage IV);
  • Female patients who are pregnancy or lactation;
  • Uncontrollable puncture site infection or systemic infection;

Interventions

DEVICEGILUPI CellCollector®

Use of GILUPI CellCollector® to detect CTC


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT05360290


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