Идёт набор NCT06373055

Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics

— Наблюдательное Muscle-invasive Bladder Cancer

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: В протоколе указаны: neoadjuvant chemotherapy followed by radical cystectomy.
Кому может быть актуально: Состояния в реестре: Muscle-invasive Bladder Cancer. Базовые параметры: 18 лет — 80 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: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.

Вмешательства

Другое neoadjuvant chemotherapy followed by radical cystectomy
combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy

Первичные конечные точки

Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles [Срок оценки: At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC))]

Вторичные конечные точки (4)

overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy [Срок оценки: within 10 years after the neoadjuvant chemotherapy and radical cystectomy]
cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy [Срок оценки: within 10 years after the neoadjuvant chemotherapy and radical cystectomy]
progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy [Срок оценки: within 10 years after the neoadjuvant chemotherapy and radical cystectomy]
recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy [Срок оценки: within 10 years after the neoadjuvant chemotherapy and radical cystectomy]

Критерии участия

Критерии включения

Suspicious of bladder cancer scheduled to have transurethral resection of bladder tumor
Consent to the provision of their biospecimen.
Willing to cooperate with this study and comply with the restrictions.
Voluntarily signed the consent form for participation in the study.
Age ≥18.