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

July 2, 2024 updated by: Yunnan Cancer Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Histology Paraffin dyeing
Experimental: ROSE technique
Diagnostic test: Experimental: ROSE technique stain
The ROSE technical group uses Diff-Quick stain for diagnosis
No Intervention: Cytological HE staining
No Intervention: Cytological Pap staining

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The time taken to diagnose using the ROSE technique
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunnan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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