Clinical trial · Observational
the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geneswell BCT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- low risk
- description
- BCT Score \<4
- interventionNames
- Diagnostic Test: Geneswell BCT
- label
- high risk
- description
- BCT Score ≥4
- interventionNames
- Diagnostic Test: Geneswell BCT
Primary outcomes (1)
- measure
- Comparative assessment between risk groups
- timeFrame
- Month 9
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available