Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorYunnan Cancer Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients had pathologically confirmed primary breast cancer
Surgical treatment was available
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Experimental: ROSE technique stain
Diagnostic testThe ROSE technical group uses Diff-Quick stain for diagnosis
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Histology Paraffin dyeingNo intervention 0 interventions
Group B: ROSE techniqueExperimental treatment 1 intervention
Group C: Cytological HE stainingNo intervention 0 interventions
Group D: Cytological Pap stainingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The number of positive and negative lymph nodes diagnosed by ROSE technique
Time frame
up to 2 yearsSecondary outcomes
1
The time taken to diagnose using the ROSE technique
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov