A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Comparative assessment between risk groups
Study Overview
Brief Summary
Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2)
- •Axillary lymph node assessment : pN0 or PN1
- •Women aged 18 and over
- •Patients without chemotherapy after operation
Exclusion Criteria
- •Patients with negative hormone receptor （both estrogen and progesterone receptor are negative）
- •Human epidermal growth factor receptor 2 （HER2） positive
- •Pathological nodule evaluation: pN2 or pN3
- •Male patients
- •Patients receiving chemotherapy after surgery
Outcomes
Primary Outcomes
Comparative assessment between risk groups
Time Frame: Month 9
By evaluating the 5-year disease-free survival rate (DFS) of patients in high and low risk groups, the statistical differences between the two groups were compared.
Secondary Outcomes
No secondary outcomes reported