Меню
Идёт набор NCT02511288

LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer

Наблюдательное Carcinoma, Non-Small-Cell Lung

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Carcinoma, Non-Small-Cell Lung. 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 →
Официальное название

Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer

Обзор

The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies

Подробное описание

Lung cancers are the first cause of death by cancer in the world. The majority of these patients are diagnosed at a late stage, non-eligible to a curative treatment. Due to tumoral genomic identification, it has been possible to classify NSCLC in molecular subtypes according to molecular abnormalities detection called "drivers" which can be targeted using an appropriate treatment. This change modifies the standard treatments from the very first line of treatment particularly for patients having an EGFR mutation or an ALK or ROS1 rearrangement, with a significant benefit of progression free survival. The French NCI (INCa) recommends to identify genomic alterations of a genes panel including EGFR, KRAS, BRAF, HER2, ALK and ROS1 as well as mutations in MET exon 14. However, all the patients who benefit from a targeted therapy develop resistance after a mean duration of 10-12 months after starting the treatment. In case of progression, the tumour genetic analysis through new biopsies, enables to identify these mechanisms and then to determine if the patient can benefit or not from a third generation molecule active on these mechanisms, and to have a better understanding of the disease evolution.

The detection of these alterations is routinely performed using tissular biopsies but in 10 to 20% of the cases, it is not possible.

The detection of these molecular abnormalities in the plasma, called " liquid biopsy " is a valuable non-invasive complementary approach for these patients. It is presently used in routine for detecting the EGFR mutations at diagnosis as well as for searching EGFR T790M mutation for resistant patients.

The liquid biopsies enable to detect circulating tumoral DNA.

Первичные конечные точки

  • Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA) [Срок оценки: 5 years]
Вторичные конечные точки (8)
  • Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response [Срок оценки: 5 years]
  • Detection of the ALK and ROS1 genes translocations in the circulating DNA [Срок оценки: 5 years]
  • Evaluation of the liquid biopsies role in the tumoral monitoring [Срок оценки: 5 years]
  • Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response [Срок оценки: 5 years]
  • Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment [Срок оценки: 5 years]
  • Evaluation of the miRNAs' expression in plasma as an epigenetic factor associated to treatments response [Срок оценки: 5 years]
  • Circulating tumoral cells isolation and analysis to determine the role of non-genomic and/or phenotypic factors in the treatments response. [Срок оценки: 5 years]
  • Evaluation of the resistance mechanisms to targeted therapies [Срок оценки: 5 years]

Критерии участия

COHORT 1

Критерии включения

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
  • Inclusion at the time of diagnostic
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

Критерии исключения

\- Patients treated before their liquid biopsy

COHORT 2 Inclusion criteria

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
  • Inclusion at the time of diagnosis
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

COHORT 3 Inclusion criteria

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 status.
  • Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line)
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

Критерии исключения

\- Initiation of immunotherpy before their liquid biopsy

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 · 8 центров
  • Centre Hospitalier Annecy Genevois — Annecy
  • CH Fleyriat — Bourg-en-Bresse
  • Hôpital Louis Pradel — Bron
  • CHU Grenoble Alpes — Grenoble
  • Centre Léon Bérard — Lyon
  • CHRU de Saint-Etienne — Saint-Priest-en-Jarez
  • Institut de Cancérologie Lucien Neuwirth — Saint-Priest-en-Jarez
  • Hôpital Nord Ouest — Villefranche-sur-Saône

Идентификаторы

NCT: NCT02511288 · ET15-076 LIBIL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗