Идёт набор NCT05375370

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA

Без фазы С лечением Hepatocellular Carcinoma

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: circulating tumor DNA dosage.
Кому может быть актуально: Состояния в реестре: Hepatocellular Carcinoma. 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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Официальное название

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study

Обзор

The goal of the REMNANT study is to confirm the clinical value of detecting a new biomarker, ctDNA (circulating tumor DNA), in the follow-up of patients with operated liver cancer. In order to meet this objective, this biomarker will be measured in your blood before and after surgery, at three and six months.

Подробное описание

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and develops in 80% of cases in the context of underlying cirrhosis1. Surgical resection, percutaneous destruction and liver transplantation are the three treatments considered curative with a non-negligible risk of recurrence of 35-50% at 2 years2.

Several data in the literature suggest that small subclinical tumors can be detected by circulating tumor DNA (ctDNA), and that the amount of tcDNA detected seems to correlate with risk factors for recurrence such as tumor size or microvascular invasion3, 4.

The objective of this pilot study is to evaluate the detection of ctDNA following tumor ablation and its impact on early recurrence.

Вмешательства

Другое circulating tumor DNA dosage
blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma

Первичные конечные точки

Change in tcNA dosage between baseline and 6 Months [Срок оценки: 6 months]
Change in tcDNA dosage between baseline and 3 Months [Срок оценки: 3 months]

Вторичные конечные точки (1)

Survival at 2 years [Срок оценки: 2 years]

Критерии участия

Критерии включения

Age ≥ 18 years
HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma.
HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above)
Patient operated on for liver resection or radiofrequency destruction
Treatment decision validated by the digestive oncology PCR
Patient having read and understood the information letter and signed the non-opposition form
Patient follow-up at the Charles Nicolle University Hospital in Rouen