Taille préopératoire et pathologique dans le cancer du sein : une étude prospective
Concordance entre les évaluations préopératoires et les mesures de taille pathologique dans le cancer du sein : une étude observationnelle prospective
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Young-Joon Kang, Ph.D.
- Numéro de téléphone: 82 32-280-5179
- E-mail: yjkang.md@gmail.com
Lieux d'étude
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Incheon, Corée du Sud
- Recrutement
- Incheon St. Mary's Hospital
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Contact:
- Young-Joon Kang, MD, PhD
- Numéro de téléphone: 82-32-280-5179
- E-mail: yjkang.md@gmail.com
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Chercheur principal:
- Young-Joon Kang, MD, PhD
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Sous-enquêteur:
- Jae Pak Yi, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
Délai: 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.
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Within 30 days after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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)
Délai: 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. A difference of 5mm or more between preoperative and pathologic measurements is defined as discordance. |
Within 30 days after surgery
|
|
Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
Délai: Within 30 days after surgery
|
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
|
|
Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
Délai: Within 30 days after surgery
|
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
Délai: 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)
Délai: Within 30 days after surgery
|
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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Carcinome du sein in situ
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Maladies de la peau
- Maladies du sein
- Carcinome
- Tumeurs canalaires, lobulaires et médullaires
- Carcinome in situ
- Maladies de la peau et du tissu conjonctif
- Tumeurs mammaires
- Carcinome intracanalaire non infiltrant
Autres numéros d'identification d'étude
- PREPARE-01
Informations sur les médicaments et les dispositifs, documents d'étude
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