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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06495736

Enrollment

400

Registered

2024-07-11

Start date

2024-02-01

Completion date

2026-02-28

Last updated

2024-07-11

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

Conditions

Breast Cancer

Brief summary

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

Interventions

DIAGNOSTIC_TESTExperimental: ROSE technique stain

The ROSE technical group uses Diff-Quick stain for diagnosis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
The number of positive and negative lymph nodes diagnosed by ROSE technique	up to 2 years

Secondary

Measure	Time frame
The time taken to diagnose using the ROSE technique	up to 2 years

Countries

China

Contacts

Primary ContactQi Tang, Doctor's degree

tangqi@kmmu.edu.cn13577174366

Outcome results

None listed

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