NCT06495736

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

June 25, 2024

Last Update Submit

July 2, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The number of positive and negative lymph nodes diagnosed by ROSE technique

    up to 2 years

Secondary Outcomes (1)

  • The time taken to diagnose using the ROSE technique

    up to 2 years

Study Arms (4)

Histology Paraffin dyeing

NO INTERVENTION

ROSE technique

EXPERIMENTAL
Diagnostic Test: Experimental: ROSE technique stain

Cytological HE staining

NO INTERVENTION

Cytological Pap staining

NO INTERVENTION

Interventions

Experimental: ROSE technique stainDIAGNOSTIC_TEST

The ROSE technical group uses Diff-Quick stain for diagnosis

ROSE technique

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Qi Tang, Doctor's degree

CONTACT

13577174366tangqi@kmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 11, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

July 11, 2024

Record last verified: 2024-06

Locations

CN(1)