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Идёт набор NCT06658080

Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

— Наблюдательное Breast Cancer Metastatic Hydrothorax Ascites Organoids

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: organoid drug test.
Кому может быть актуально
Состояния в реестре: Breast Cancer Metastatic, Hydrothorax, Ascites, Organoids. Базовые параметры: 18 лет — 70 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
Китай
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

Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer

Обзор

Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.

Подробное описание

90 metastatic breast cancer patients with hydrothorax and ascitic fluid will be recruited. Baseline data, including medical history, ultrasound, and MRI records, will be collected both before and after two cycles of chemotherapy. Tumor samples from hydrothorax and ascitic fluid will be obtained and cultured to generate patient-derived organoids (PDOs). These PDOs will then be exposed to standard chemotherapeutic drugs used in breast cancer treatment. Organoid growth will be monitored post-treatment, and dose-response curves will be generated to assess drug sensitivity. To evaluate clinical outcomes, the RECIST criteria will be applied to measure tumor response in patients. Correlation analysis will be performed to determine the consistency between the treatment responses observed in the PDO models and the actual clinical outcomes of the patients.

Вмешательства

  • Диагностический тест organoid drug test
    Before initiating therapy, patients diagnosed with metastatic breast cancer patients with hydrothorax and ascite fluid. The hydrothorax and ascite fluid is utilized to establish organoids and conduct drug testing.

Первичные конечные точки

  • Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes. The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes. [Срок оценки: 2024.10-2026.10]
Вторичные конечные точки (1)
  • The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment. [Срок оценки: 2024.10-2026.10]

Критерии участия

Критерии включения

  • Signed informed consent form and willingness to participate in the clinical study.
  • patients aged between 18 and 70 years old.
  • Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab.
  • ECOG performance status score of 0-1.
  • No significant abnormalities in liver and kidney function (BIL <1.5-fold upper limit of normal (ULN)；ALT<2.5×ULN; AST<2.5×ULN；Crea≤1×ULN).

Критерии исключения

1.Patients not suitable for chemotherapy and target therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 3 центра
  • Second affiliated hospital of zhejiang university — Ханчжоу
  • Zhejiang Cancer Hospital — Ханчжоу
  • 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу

Идентификаторы

NCT: NCT06658080 · 2024-0866

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗