Application of Rapid On-site Evaluation in Lymph Node Bio... | NCT06495736

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

NCT06495736

Sponsor

Yunnan Cancer Hospital

Status

Unknown status

Last Update Posted

Jul 11, 2024Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Experimental: ROSE technique stain

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Jun 25, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Experimental: ROSE technique stain	Diagnostic Test	The ROSE technical group uses Diff-Quick stain for diagnosis	ROSE technique

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Tang, Doctor's degree	Contact	13577174366		tangqi@kmmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yunnan Cancer Hospital	Recruiting	Kunming	Yunnan		China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided