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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04179318
Enrollment
100
Registered
2019-11-27
Start date
2020-02-01
Completion date
2020-12-31
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DIAGNOSTIC_TESTGeneswell BCT

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.

Sponsors

The Affiliated Hospital of Hangzhou Normal University
CollaboratorOTHER
Korea University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Comparative assessment between risk groupsMonth 9By 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026