CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
Recruiting · NCT05360290 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
GILUPI CellCollector®
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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;
Where it is running
1 location listed.
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University - Shanghai, Shanghai Municipality, China