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

NCT ID: NCT06495736

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Histology Paraffin dyeing

Group Type NO_INTERVENTION

No interventions assigned to this group

ROSE technique

Group Type EXPERIMENTAL

Experimental: ROSE technique stain

Intervention Type DIAGNOSTIC_TEST

The ROSE technical group uses Diff-Quick stain for diagnosis

Cytological HE staining

Group Type NO_INTERVENTION

No interventions assigned to this group

Cytological Pap staining

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: ROSE technique stain

The ROSE technical group uses Diff-Quick stain for diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yunnan Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Tang, Doctor's degree

Role: CONTACT

13577174366

Facility Contacts

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Hui Li, Master's degree

Role: primary

18468212816

Other Identifiers

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2024.76

Identifier Type: -

Identifier Source: org_study_id

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