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CompletedNCT05961280Updated Jul 27, 2023

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

An observational study in Ductal Carcinoma in Situ, sponsored by Gangnam Severance Hospital. Completed. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Gangnam Severance Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
385
Ages
19 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Ductal Carcinoma in Situ
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 385 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients who received breast-conserving surgery
  2. Patients who had concurrent contralateral invasive breast cancer
  3. Patients who were in case of ipsilateral breast tumor recurrence
  4. Patients whose invasiveness was uncertain in the biopsy samples
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
385 participants (actual)
Patient registry
No

Groups and cohorts

  • DCIS Mastectomy

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

    Procedure: Mastectomy with sentinel lymph node biopsy

Interventions

  • ProcedureMastectomy with sentinel lymph node biopsy
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What researchers measure

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.

    Time frame: up to 2 weeks after surgery

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05961280
Lead sponsor
Gangnam Severance Hospital
Responsible party
Joon Jeong (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Jul 27, 2023
Start date
Jan 1, 2010
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Jul 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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