Selective Omission of Sentinel Lymph Node Biopsy in Maste... | NCT05961280

Studies
Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

NCT05961280

Sponsor

Gangnam Severance Hospital

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

385Actual

Phase

Not provided

Conditions

Ductal Carcinoma in Situ

Interventions

Mastectomy with sentinel lymph node biopsy

Countries

Not provided

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Jul 6, 2023

First Submission Date that Met QC Criteria

Jul 17, 2023

First Posted Date

Jul 27, 2023Actual

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 17, 2023

Last Update Posted Date

Jul 27, 2023Actual

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

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

385Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCIS Mastectomy		Patients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy	Procedure: Mastectomy with sentinel lymph node biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mastectomy with sentinel lymph node biopsy	Procedure		DCIS Mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axillary lymph node metastasis rate	Our primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery.	up to 2 weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy
Women underwent curative surgery for DCIS

Exclusion Criteria:

Patients who received breast-conserving surgery
Patients who had concurrent contralateral invasive breast cancer
Patients who were in case of ipsilateral breast tumor recurrence
Patients whose invasiveness was uncertain in the biopsy samples

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D002285	Carcinoma, Intraductal, Noninfiltrating

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008408	Mastectomy
D021701	Sentinel Lymph Node Biopsy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided