DCISNCT05912569
Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
A study testing Delay sentinel node biopsy in people with DCIS, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- DCIS
- What is being tested?
- Delay sentinel node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2023to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 75 years old.
- Patients diagnosed with DCIS through histological examination.
- Patients undergoing mastectomy
Who cannot join
- In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
- In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
- In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyeong-Gon Moon, MD, 02-2072-2634, moonhgsurgi@gmail.com
Eunhye Kang, MD, 02-2072-2817, rkd4327@naver.com
About this study
Official title: Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.
primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.
Read the detailed description
Primary surgery:
Patients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included.
Prior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice.
total mastectomy surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures (Maxon 3-0, a slow monofilament absorbable suture).
The number of marked sentinel lymph nodes is recorded for documentation.
Confirmation of pathological examination results:
If the final surgical specimen confirms invasive carcinoma (size > 1mm) through pathological examination, sentinel lymph node surgery is performed.
addendum)
- Suture Specification The surgical procedure will utilize Maxon 3-0, a slow monofilament absorbable suture for optimal tissue approximation and healing.
- Management of Microinvasive Cancer For cases where the tumor size is 1 mm or smaller (microinvasive cancer), the decision to proceed with reoperation will be made at the discretion of the treating physician based on clinical judgment.
Secondary surgery:
Prior to the surgery, an axillary view x-ray is taken to verify the location and number of the clips.
Blue dye and/or radioisotope injection is administered near the axillary incision site.
Accessing the axillary region involves identifying the marked areas using clips or sutures and detecting sentinel lymph nodes for biopsy.
The number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping.
addendum) Axillary X-ray and Sentinel Node Mapping Axillary x-ray and the use of blue dye or radioisotope injection for sentinel lymph node mapping are not mandatory and may be utilized at the physician's discretion.
- Conditions
- DCIS
- Being tested
- Delay sentinel node biopsy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delay sentinel node biopsyProcedure or surgery
In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I
| Study group | Role | What they receive |
|---|---|---|
| Delay sentinel node biopsy | Experimental | sinlge arm Receives: Procedure: Delay sentinel node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
Measured: 2 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Jun 2023
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCISStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912569
- Sponsor's protocol ID
- 2212-088-1386
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT05912569
- Acronym / sponsor ID
- 2212-088-1386
- Conditions
- DCIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.
primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.
Detailed description
Primary surgery:
Patients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included.
Prior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice.
total mastectomy surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures (Maxon 3-0, a slow monofilament absorbable suture).
The number of marked sentinel lymph nodes is recorded for documentation.
Confirmation of pathological examination results:
If the final surgical specimen confirms invasive carcinoma (size > 1mm) through pathological examination, sentinel lymph node surgery is performed.
addendum)
- Suture Specification The surgical procedure will utilize Maxon 3-0, a slow monofilament absorbable suture for optimal tissue approximation and healing.
- Management of Microinvasive Cancer For cases where the tumor size is 1 mm or smaller (microinvasive cancer), the decision to proceed with reoperation will be made at the discretion of the treating physician based on clinical judgment.
Secondary surgery:
Prior to the surgery, an axillary view x-ray is taken to verify the location and number of the clips.
Blue dye and/or radioisotope injection is administered near the axillary incision site.
Accessing the axillary region involves identifying the marked areas using clips or sutures and detecting sentinel lymph nodes for biopsy.
The number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping.
addendum) Axillary X-ray and Sentinel Node Mapping Axillary x-ray and the use of blue dye or radioisotope injection for sentinel lymph node mapping are not mandatory and may be utilized at the physician's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delay sentinel node biopsy | Experimental | Procedure: Delay sentinel node biopsysinlge arm |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 to 75 years old.
- Patients diagnosed with DCIS through histological examination.
- Patients undergoing mastectomy
Key exclusion criteria (4 listed)
- In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
- In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
- In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
- Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delay sentinel node biopsyIn the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I | Procedure or surgery | Delay sentinel node biopsy |
Primary outcome
success rate
Time frame: 2 weeks later
The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for DCIS
Active, not recruitingObservational study
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
DCIS
Recruiting
Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer
Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC))
Recruiting
Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS
RecruitingPhase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
Invasive Ductal Breast Carcinoma, Invasive Ductal Carcinoma, Breast
RecruitingPhase 2
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Breast Cancer, Early-stage Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delay sentinel node biopsy in people with DCIS, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 2 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.