Tamaño preoperatorio versus patológico en el cáncer de mama: un estudio prospectivo
Concordancia entre evaluaciones preoperatorias y mediciones de tamaño patológico en cáncer de mama: un estudio observacional prospectivo
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Young-Joon Kang, Ph.D.
- Número de teléfono: 82 32-280-5179
- Correo electrónico: yjkang.md@gmail.com
Ubicaciones de estudio
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Incheon, Corea del Sur
- Reclutamiento
- Incheon St. Mary's Hospital
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Contacto:
- Young-Joon Kang, MD, PhD
- Número de teléfono: 82-32-280-5179
- Correo electrónico: yjkang.md@gmail.com
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Investigador principal:
- Young-Joon Kang, MD, PhD
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Sub-Investigador:
- Jae Pak Yi, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
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
Exclusion Criteria:
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Breast cancer surgery group
This cohort includes all patients undergoing breast cancer surgery who are enrolled in the study. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
Periodo de tiempo: Within 30 days after surgery
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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.
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Within 30 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
Periodo de tiempo: Within 30 days after surgery
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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. |
Within 30 days after surgery
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Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
Periodo de tiempo: Within 30 days after surgery
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To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS). |
Within 30 days after surgery
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Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
Periodo de tiempo: Within 30 days after surgery
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To assess the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients who received neoadjuvant systemic therapy |
Within 30 days after surgery
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Proportion of surgical method change: rates of unnecessary total mastectomy
Periodo de tiempo: Within 30 days after surgery
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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. |
Within 30 days after surgery
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Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)
Periodo de tiempo: Within 30 days after surgery
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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. |
Within 30 days after surgery
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Rate of recurrence within 1-year after breast surgery
Periodo de tiempo: Within 1 year after enroll
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The proportion of patients who develop new malignant lesions during the follow-up period within 1 year after breast surgery. |
Within 1 year after enroll
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Carcinoma de mama in situ
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Enfermedades de la piel
- Enfermedades de los senos
- Carcinoma
- Neoplasias ductales, lobulillares y medulares
- Carcinoma in situ
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Carcinoma Intraductal No Infiltrante
Otros números de identificación del estudio
- PREPARE-01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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