the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis

NCT ID: NCT04179318

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

low risk

BCT Score \<4

Geneswell BCT

Intervention Type: DIAGNOSTIC_TEST

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.

high risk

BCT Score ≥4

Geneswell BCT

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Geneswell 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: collaborator

Korea University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

YANWQ002

Identifier Type: -

Identifier Source: org_study_id