Oncologic Outcomes of Minimal Access Nipple-sparing Maste... | NCT07069803

Studies
Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer

NCT07069803

Sponsor

Changhua Christian Hospital

Status

Completed

Last Update Posted

Jul 17, 2025Actual

Enrollment

1,129Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

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 2025

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

Feb 1, 2000Actual

Primary Completion Date

Mar 30, 2024Actual

Completion Date

Mar 30, 2024Actual

First Submitted Date

Jun 26, 2025

First Submission Date that Met QC Criteria

Jul 7, 2025

First Posted Date

Jul 17, 2025Actual

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 7, 2025

Last Update Posted Date

Jul 17, 2025Actual

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

In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer

Detailed Description

A retrospective analysis of a prospectively collected database was conducted from single institute to compare the oncologic outcomes of MA-NSM versus C-NSM. The clinical results and oncologic outcome (margin involved rate, local recurrence and overall survival) were compared between groups. To prevent bias, a case control approach was conducted with propensity score matching (PSM) method.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
minimal acccess NSM		minimal acccess NSM
conventional NSM		conventional NSM

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local recurrence	local recurrence	10 years
distant metastasis	distant metastasis	10 years
disease free survival	disease free survival	10 years
overall survival	overall survival	10 years

Secondary Outcomes

Measure	Description	Time Frame
operative duration	operative duration	during surgery
intra-operative blood loss	intra-operative blood loss	during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary operable breast cancer and had undergone NSM

Exclusion Criteria:

had metastatic disease, non-malignant breast disease cases, bilateral breast cancer cases, recurrent breast cancer as well as male breast cancer cases and patients who did not undergo NSM

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

NSM patients at CCH

Sampling Method

Probability Sample

Name	Affiliation	Role
Jun Su, MBBS, FRCS	Changhua Christian Hospital	Study Director

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