Präoperative vs. pathologische Größe bei Brustkrebs: Eine prospektive Studie
Übereinstimmung zwischen präoperativen Beurteilungen und pathologischen Größenmessungen bei Brustkrebs: eine prospektive Beobachtungsstudie
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Young-Joon Kang, Ph.D.
- Telefonnummer: 82 32-280-5179
- E-Mail: yjkang.md@gmail.com
Studienorte
-
-
-
Incheon, Südkorea
- Rekrutierung
- Incheon St. Mary's Hospital
-
Kontakt:
- Young-Joon Kang, MD, PhD
- Telefonnummer: 82-32-280-5179
- E-Mail: yjkang.md@gmail.com
-
Hauptermittler:
- Young-Joon Kang, MD, PhD
-
Unterermittler:
- Jae Pak Yi, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
Zeitfenster: 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.
|
Within 30 days after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
|
Proportion of surgical method change: rates of unnecessary total mastectomy
Zeitfenster: Within 30 days after surgery
|
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
|
|
Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)
Zeitfenster: 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
|
|
Rate of recurrence within 1-year after breast surgery
Zeitfenster: Within 1 year after enroll
|
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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Brustkrebs in situ
- Neubildungen nach Standort
- Neubildungen
- Neubildungen nach histologischem Typ
- Neubildungen, Drüsen und Epithelien
- Adenokarzinom
- Hautkrankheiten
- Brusterkrankungen
- Karzinom
- Neubildungen, duktale, lobuläre und medulläre
- Karzinom in situ
- Haut- und Bindegewebserkrankungen
- Neoplasien der Brust
- Karzinom, intraduktal, nichtinfiltrierend
Andere Studien-ID-Nummern
- PREPARE-01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .