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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05360290
Other study ID # KY2022-044-B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date June 2029

Study information

Verified date November 2023
Source RenJi Hospital
Contact Wenji Yin
Phone 86(21)68385569
Email followroad@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 484
Est. completion date June 2029
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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;

Study Design


Intervention

Device:
GILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC

Locations

Country Name City State
China Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary invasive disease-free survival (iDFS) Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause. From surgery until time of event up to 3 years
Secondary pathological complete response (pCR) ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is at surgery
Secondary overall Survival (OS) Overall survival is defined as the time from randomization to death from any cause. From surgery until time of event up to 3 years
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