Analysis of Circulating Tumor Markers in Blood - ALCINA 5

Обзор

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

Подробное описание

The new major challenge in research focuses on the rapid evaluation of circulating biomarker candidates, which could replace or complement molecular analyses of tumor tissue obtained through biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.

The study ALCINA 5 relies exactly on the principle of small cohorts based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy. Which cohort correspond each to a clinical situation and/or a technique of different implemented detection. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).

Вмешательства

• Биопрепарат Blood sampling C1
  Blood samples will be collected at four key time points : * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4).

Первичные конечные точки

• All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers. [Срок оценки: 10 years]

Вторичные конечные точки (1)

• COHORT 1 - CURE : to define a liquid biopsy signature for predicting therapeutic response from samples taken before initiation of immunotherapy (T1). [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
• 18 years old or higher ?
• Patient who has provided informed, written, and explicit consent,
• Patient affiliated with a French Social Protection System.

In the case of a tumor biopsy:

• Tumor considered as accessible by biopsy,
• Normal hemostasis assessment (PT, APTT, platelets),
• No anticoagulant or antiaggregant treatment for the biopsy.

Критерии исключения

• Pregnant woman and/or breast-feeding,
• Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
• Private persons of freedom or under guardianship,
• Patient with a history of other invasive cancers within the 5 years preceding inclusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle — Montpellier

Идентификаторы

NCT: NCT07060950 · PROICM 2022-02 ALC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗