Breast Cancer Clinical Trial
Official title:
A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Verified date | October 2019 |
Source | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Korea University, The Affiliated Hospital of Hangzhou Normal University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparative assessment between risk groups | 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. | Month 9 |
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