NCT05961280

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

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

January 1, 2010

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

12 years

First QC Date

July 6, 2023

Last Update Submit

July 17, 2023

Conditions

Ductal Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

DCIS Mastectomy

Patients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy

Procedure: Mastectomy with sentinel lymph node biopsy

Interventions

Mastectomy with sentinel lymph node biopsyPROCEDURE
DCIS Mastectomy

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

MastectomySentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalLymph Node ExcisionInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 27, 2023

Study Start

January 1, 2010

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 27, 2023

Record last verified: 2023-07