MastectomyNCT06505577
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
An observational study of Mastectomy and Breast Neoplasm Malignant Primary, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mastectomy, Breast Neoplasm Malignant Primary
- What is being tested?
- No additional intervention
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2024to 30 Aug 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be enrolled from patients at Incheon Saint Mary's Hospital, a 1000-bed tertiary academic medical center located in Incheon, South Korea.
Who may be able to join
- Adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ).
- Patients scheduled for surgical resection of the tumor Availability of both preoperative tumor size assessments and pathologic measurements post-surgery
Who cannot join
- Patients with recurrent breast cancer Inflammatory breast cancer Patients who did not undergo surgery Patients whose preoperative tumor size data is not available or deficient for analyzing
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
Incheon St. Mary's Hospital
Incheon
Young-Joon Kang, MD, PhD, 82-32-280-5179, yjkang.md@gmail.com
Young-Joon Kang, MD, PhD
About this study
Official title: Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis.
Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.
Read the detailed description
Breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. While breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. The challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. Many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. Despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.
- Conditions
- Mastectomy, Breast Neoplasm Malignant Primary
- Being tested
- No additional intervention
- Keywords
- Breast cancer, Mastectomy, Ductal carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No additional interventionOther
All patients are scheduled to undergo standard breast surgery as part of their routine clinical care. No additional interventions are administered specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer surgery group | This cohort includes all patients undergoing breast cancer surgery who are enrolled in the study. Receives: Other: No additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer.
- Using the scale of Landis and Koch according to the intraclass correlation coefficient.
- With/without MRI status. To identify and evaluate factors associated with discrepancies between preoperative assessments and pathologic measurements.
Measured: Within 30 days after surgery
Secondary outcomes (6)
Concordance rate by size discordance (5mm) To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS)
To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer. A difference of 5mm or more between preoperative and pathologic measurements is defined as discordance.
Measured: Within 30 days after surgery
Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS).
Measured: Within 30 days after surgery
Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
To assess the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients who received neoadjuvant systemic therapy
Measured: Within 30 days after surgery
Proportion of surgical method change: rates of unnecessary total mastectomy
To determine the rate of change in surgical method (e.g., from lumpectomy to mastectomy, nipple-sparing to skin-sparing, or vice versa) based on discrepancies between preoperative tumor size assessments and pathologic measurements. This involves collecting the initial surgical method plan from the surgeon before the surgery and, after confirming the pathological size post-surgery, collecting the final surgical method deemed feasible for the patient from the surgeon.
Measured: Within 30 days after surgery
Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)
To determine the associated factors contributing to size discrepancies between mammography (with or without breast ultrasonography) and MRI. For analyzing the clinical factors that necessitate the use of MRI to predict the pathologic tumor size.
Measured: Within 30 days after surgery
Rate of recurrence within 1-year after breast surgery
The proportion of patients who develop new malignant lesions during the follow-up period within 1 year after breast surgery.
Measured: Within 1 year after enroll
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yonsei University
- Responsible party
- Principal investigator, Young-Joon Kang, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505577
- Sponsor's protocol ID
- PREPARE-01
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2024
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06505577
- Acronym / sponsor ID
- PREPARE-01
- Conditions
- Mastectomy, Breast Neoplasm Malignant Primary
- Keywords
- Breast cancer, Mastectomy, Ductal carcinoma in situ
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Collaborators
- Yonsei University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 17 Jul 2024 (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.
Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis.
Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.
Detailed description
Breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. While breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. The challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. Many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. Despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer surgery group | – | Other: No additional interventionThis cohort includes all patients undergoing breast cancer surgery who are enrolled in the study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be enrolled from patients at Incheon Saint Mary's Hospital, a 1000-bed tertiary academic medical center located in Incheon, South Korea.
Key inclusion criteria (2 listed)
- Adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ).
- Patients scheduled for surgical resection of the tumor Availability of both preoperative tumor size assessments and pathologic measurements post-surgery
Key exclusion criteria (1 listed)
- Patients with recurrent breast cancer Inflammatory breast cancer Patients who did not undergo surgery Patients whose preoperative tumor size data is not available or deficient for analyzing
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 |
|---|---|---|
| No additional interventionAll patients are scheduled to undergo standard breast surgery as part of their routine clinical care. No additional interventions are administered specifically for this study. | Other | Breast cancer surgery group |
Primary outcome
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
Time frame: Within 30 days after surgery
To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer. * Using the scale of Landis and Koch according to the intraclass correlation coefficient. * With/without MRI status. To identify and evaluate factors associated with discrepancies between preoperative assessments and pathologic measurements.
6 secondary outcomes
Concordance rate by size discordance (5mm) To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS)
Time frame: Within 30 days after surgery
Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
Time frame: Within 30 days after surgery
Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
Time frame: Within 30 days after surgery
Proportion of surgical method change: rates of unnecessary total mastectomy
Time frame: Within 30 days after surgery
Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)
Time frame: Within 30 days after surgery
Rate of recurrence within 1-year after breast surgery
Time frame: Within 1 year after enroll
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 6 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy and Breast Neoplasm Malignant Primary, run by Incheon St.Mary's 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 2 inclusion and 1 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 6 Apr 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?
Contact Young-Joon Kang, Ph.D. (82 32-280-5179, yjkang.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies (time frame: Within 30 days 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 6 Apr 2025.