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Набор скоро начнётся NCT07735793

A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea

— Наблюдательное Urinary Bladder Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Urinary Bladder Neoplasms. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea

Обзор

The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) who have undergone radical cystectomy (surgical procedure to remove entire urinary bladder). NMIBC is a type of bladder cancer in which cancer is confined to innermost lining of the bladder and MIBC is a type of bladder cancer in which cancer has grown deep into the thick muscle of the bladder.

Первичные конечные точки

  • Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC) [Срок оценки: Up to 12 months post RC procedure]
  • Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC [Срок оценки: Up to 3 years post RC procedure]
  • Cohort B: Mortality Within 30 days After RC [Срок оценки: Up to 30 days post RC procedure]
  • Cohort B: Mortality Within 90 days After RC [Срок оценки: Up to 90 days post RC procedure]
  • Cohort B: Length Of Stay (LOS) for Hospitalization for RC [Срок оценки: Up to 3 years post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 30 Days After RC [Срок оценки: Up to 30 days post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 90 Days After RC [Срок оценки: Up to 90 days post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 12-Months After RC [Срок оценки: Up to 12-month post RC procedure]
  • Cohort B: Number of Hospital Visits Within 12-Months After RC [Срок оценки: Up to 12 months post RC procedure]
  • Cohort B: Number of Hospital Visits Within 3 Years After RC [Срок оценки: Up to 3 years post RC procedure]
Вторичные конечные точки (12)
  • Cohort A: Percentage of Participants by Bladder Cancer Stage [Срок оценки: At Baseline]
  • Cohort A: Treatment Patterns: Type of Treatment [Срок оценки: Up to approximately 5 years]
  • Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy [Срок оценки: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy [Срок оценки: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles [Срок оценки: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Total Duration of BCG Therapy [Срок оценки: Up to approximately 5 years]
  • Cohort B: Time from Diagnosis to RC [Срок оценки: Up to approximately 8 years]
  • Cohort B: Time from Last BCG to RC [Срок оценки: Up to approximately 8 years]
  • Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure [Срок оценки: Up to 12 months post RC procedure]
  • Cohort B: Total Costs from Diagnosis to RC [Срок оценки: Up to approximately 8 years]
  • Cohort B: Total Costs for the Period after RC [Срок оценки: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure]
  • Cohort B: Total Cost for Hospitalization for RC [Срок оценки: Up to approximately 8 years]

Критерии участия

Критерии включения

  • Participants newly diagnosed with bladder cancer (BC) (International statistical classification of diseases and related health problems, 10th revision \[ICD-10\] codes of malignant neoplasm of the bladder \[C67\] or carcinoma in-situ of bladder \[D090\] and cancer-specific insurance code of Korean national health insurance service \[V193\]) between September 1 2015 and August 31 2023
  • Having two outpatients or one inpatient visit anytime in the study period for BC

Критерии исключения

  • Participants with a history of BC diagnosis or cystectomy during the pre-index period
  • Participants with prior primary malignancy (ICD-10 codes) that was under active treatment or follow-up during the pre-index period
  • Participants with evidence of metastatic disease at the index date, defined as: a. Having secondary malignancy codes (ICD-10 codes), or b. Having received systemic chemotherapy for BC within 6 months of the initial transurethral resection of the bladder tumor (TURBT)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07735793 · 17000139BLC4008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗