Breast CancerNCT05797454
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer
A study testing Wire-guided localization and marker clip localization and Wire-guided localization in people with Breast Cancer and Breast-conserving Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast-conserving Surgery
- What is being tested?
- Wire-guided localization and marker clip localization and Wire-guided localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to 1 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients, age≥18 year
- A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
- Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
- Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
Who cannot join
- Inflammatory breast cancer or Paget's disease
- Breast deformities and other conditions that impact breast conservation success rate
- Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
- Pregnancy or lactation
- Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
- Patients with stage IV diseases or unresectable lesions in either breast
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- Patients combined with other diseases that may affect survival
- Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations
- Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Gong Chang, doctor, 02034070499, changgong282@163.com
About this study
Official title: Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Read the detailed description
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
- Conditions
- Breast Cancer, Breast-conserving Surgery
- Being tested
- Wire-guided localization and marker clip localization, Wire-guided localization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wire-guided localization and marker clip localizationProcedure or surgery
Positioning guide wire and marker clip in the center of the lesion
Wire-guided localizationProcedure or surgery
Positioning guide wire in the center of the lesion
| Study group | Role | What they receive |
|---|---|---|
| Untreated patients-combined localization | Experimental | In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation Receives: Procedure: Wire-guided localization and marker clip localization |
| Untreated patients-single localization | Active comparator | In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation Receives: Procedure: Wire-guided localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive margin rate
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.
Measured: up to 3 months
Secondary outcomes (3)
Re-operation rate
the proportion of patients which have a positive margin and requires reoperation
Measured: up to 3 months after first operation
The proportion of breast-conserving surgery
It refers to the proportion of patients who have successfully undergone breast-conserving surgery.
Measured: up to 3 months after first operation
IDFS
Time from surgery to the first occurrence of local, distant disease recurrence, or death.
Measured: 2 years, 3 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start17 Feb 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797454
- Sponsor's protocol ID
- SYSKY-2023-129-01
- Status last verified
- Jul 2024
- First submitted
- 26 Feb 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05797454
- Acronym / sponsor ID
- SYSKY-2023-129-01
- Conditions
- Breast Cancer, Breast-conserving Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Apr 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.
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Detailed description
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Untreated patients-combined localization | Experimental | Procedure: Wire-guided localization and marker clip localizationIn untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation |
| Untreated patients-single localization | Active comparator | Procedure: Wire-guided localizationIn untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female patients, age≥18 year
- A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
- Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
- Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
Key exclusion criteria (9 listed)
- Inflammatory breast cancer or Paget's disease
- Breast deformities and other conditions that impact breast conservation success rate
- Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
- Pregnancy or lactation
- Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
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 |
|---|---|---|
| Wire-guided localization and marker clip localizationPositioning guide wire and marker clip in the center of the lesion | Procedure or surgery | Untreated patients-combined localization |
| Wire-guided localizationPositioning guide wire in the center of the lesion | Procedure or surgery | Untreated patients-single localization |
Primary outcome
positive margin rate
Time frame: up to 3 months
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.
3 secondary outcomes
Re-operation rate
Time frame: up to 3 months after first operation
The proportion of breast-conserving surgery
Time frame: up to 3 months after first operation
IDFS
Time frame: 2 years, 3 years, and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wire-guided localization and marker clip localization and Wire-guided localization in people with Breast Cancer and Breast-conserving Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Gong, doctor (02034070499, changgong282@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive margin rate (time frame: up to 3 months). 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 3 Jul 2024.