the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis

Zhejiang University

Status: Unknown

Conditions: Breast Cancer

Treatments: Diagnostic Test: Geneswell BCT

Study type: Observational

Funder types: Other

Identifiers

NCT04179318

YANWQ002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

low risk

Description:

BCT Score \<4

Treatment:

Diagnostic Test: Geneswell BCT

high risk

Description:

BCT Score ≥4

Treatment:

Diagnostic Test: Geneswell BCT