Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer

Yunnan Cancer Hospital

Status: Enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: Experimental: ROSE technique stain

Study type: Interventional

Funder types: Other

Identifiers

NCT06495736

2024.76

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the value of rapid on-site evaluation（ROSE） in lymph node biopsy of breast cancer. The main question it aims to answer is:The ROSE technique was applied to breast cancer lymph node biopsy to improve the diagnostic efficiency and accuracy.

Participants underwent routine lymph node biopsy, and the test personnel conducted routine disease examination and rose technique evaluation on the removed ly

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients had pathologically confirmed primary breast cancer
• Surgical treatment was available

Exclusion criteria

• Previous history of surgery on the affected axilla, internal breast or chest
• Pregnant or breastfeeding patients
• Previous radiotherapy or chemotherapy
• Complicated history of other tumors

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Histology Paraffin dyeing

No Intervention group

ROSE technique

Experimental group

Treatment:

Diagnostic Test: Experimental: ROSE technique stain

Cytological HE staining

No Intervention group

Cytological Pap staining

No Intervention group