Идёт набор NCT06416397

Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

— Наблюдательное Cholangiocarcinoma

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: Proteomic profile.
Кому может быть актуально: Состояния в реестре: Cholangiocarcinoma. Базовые параметры: от 18 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 →

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Обзор

The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).

Подробное описание

Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.

New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.

Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.

Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.

Вмешательства

Диагностический тест Proteomic profile
Proteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken. Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resource

Первичные конечные точки

positive diagnosis of cholangiocarcinoma [Срок оценки: Baseline]

Вторичные конечные точки (3)

Identification of diagnostic biomarkers for cholangiocarcinoma [Срок оценки: Baseline]
differential diagnosis rates [Срок оценки: Baseline]
positive diagnoses with the Next-Generation Sequencing technique [Срок оценки: Baseline]

Критерии участия

Критерии включения

Patient 18 years and older
Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management
Oral consent