Ductal Carcinoma in SituNCT05961280
Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates
An observational study of Ductal Carcinoma in Situ, run by Gangnam Severance Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Mastectomy with sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Upstaging and Lymph Node Metastasis Rate in Patients With Ductal Carcinoma in Situ Who Received Mastectomy Regarding the Necessary of Sentinel Lymph Node Biopsy
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.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- Mastectomy with sentinel lymph 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.
Mastectomy with sentinel lymph node biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DCIS Mastectomy | Patients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy Receives: Procedure: Mastectomy with sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2010
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961280
- Sponsor's protocol ID
- 3-2023-0026
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upstaging and Lymph Node Metastasis Rate in Patients With Ductal Carcinoma in Situ Who Received Mastectomy Regarding the Necessary of Sentinel Lymph Node Biopsy
- ClinicalTrials.gov ID
- NCT05961280
- Acronym / sponsor ID
- 3-2023-0026
- Conditions
- Ductal Carcinoma in Situ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCIS Mastectomy | – | Procedure: Mastectomy with sentinel lymph node biopsyPatients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Mastectomy with sentinel lymph node biopsy | Procedure or surgery | DCIS Mastectomy |
Primary outcome
Axillary lymph node metastasis rate
Time frame: up to 2 weeks after surgery
Our primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Related trials for Ductal Carcinoma in Situ
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Ductal Carcinoma in Situ
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ductal Carcinoma in Situ, run by Gangnam Severance Hospital.
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 2 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary lymph node metastasis rate (time frame: up to 2 weeks after surgery). 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 27 Jul 2023.