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Идёт набор NCT04970472

Bio Clinical Collection of Urothelial Carcinoma

Наблюдательное Urothelial Carcinoma 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: collection of blood, urines, stool and tumor samples.
Кому может быть актуально
Состояния в реестре: Urothelial Carcinoma, Bladder Cancer. Базовые параметры: 18 лет — 99 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this study is to collect tumor samples, urines, stool and blood from patients with urothelial carcinoma. These samples will be stored in a secure and confidential laboratory of the Toulouse University Hospital.

Подробное описание

Recent studies have shown that the bladder also harbors friendly bacteria that are collectively called the microbiome. While the effect of the bladder microbiome to health remains to be more clearly understood, an imbalance in the microbiome is associated with several urinary diseases including overactive bladder and bladder cancer. But whether the microbiome affects the outcome of Bacille Calmette et Guérin (BCG)-immunotherapy or chemotherapy in bladder cancer is still not known.

Researchers at Toulouse University Hospital want to learn as much as possible about bladder cancer. One way to do so is by studying what is in your urines, blood, stool, saliva and in your tumor.

Patients, who will be agree to take part in this study, will have at least about one tablespoon of blood (as a residual of current biological analysis), 1 container of urines, stool and saliva collected before bladder resection.

After transurethral bladder resection or radical cystectomy scheduled as part of the standard of care, some tumor samples might be collected either as fresh tissue or as paraffin embedded tissue and store in a secure and confidential laboratory at Toulouse University Hospital.

The patient's follow up will be schedule as the standard of care and no additional visit will be required for the study. Oncological outcome of each patient will be recorded up to 5 years This is an investigational study in which up to 500 patients will take part in the collection. All patients will be all enrolled at Toulouse University Hospital.

Вмешательства

  • Биопрепарат collection of blood, urines, stool and tumor samples
    blood, urines, stool will be collected during routine cares. Tumor samples from surgery will also be stored.

Первичные конечные точки

  • Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies. [Срок оценки: Day 0]
  • Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies. [Срок оценки: during the intervention/procedure/surgery]

Критерии участия

Критерии включения

  • Adult >18 years old
  • Patient with suspected or diagnosed Urothelial carcinoma
  • Patients who are willing to consent for this protocol.

Критерии исключения

  • Pregnant or breastfeeding patients
  • Patients under 18 years old
  • Patients under guardianship or curators
  • Patients unable to sign a free and informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Rangueil University Hospital — Toulouse

Идентификаторы

NCT: NCT04970472 · RC31/21/0070

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗