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Идёт набор NCT02534649

Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

Без фазы С лечением Solid Tumor Hematological Malignancy

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: Newly obtained biopsy and Blood samples collection.
Кому может быть актуально
Состояния в реестре: Solid Tumor, Hematological Malignancy. 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

This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease. In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling. Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

Подробное описание

The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.

The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.

Вмешательства

  • Процедура Newly obtained biopsy and Blood samples collection
    For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient. Patients for whom no molecular aberration has been identified will be treated at the disc

Первичные конечные точки

  • Proportion of patients presenting at least one genomic alteration [Срок оценки: 1 month]
Вторичные конечные точки (3)
  • - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) [Срок оценки: Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months]
  • Rate of molecular screening failure [Срок оценки: Molecular screening failure will be assessed at 1 month]
  • Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0. [Срок оценки: Safety will be assessed 1 month after biopsy]

Критерии участия

Критерии включения

  • Age ≥ 18 years,
  • Histology: solid malignant tumor or hematological malignancy,
  • Deleted MSA9
  • Deleted MSA9,
  • Deleted MSA9,
  • Deleted MSA9,
  • Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),
  • Voluntary signed and dated written informed consent prior to any study specific procedure.

Критерии исключения

  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Individuals deprived of liberty or placed under guardianship
  • Pregnant or breast feeding women,
  • Previous enrolment in the present study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 7 центров
  • Centre Hospitalier de la Côte Basque — Bayonne
  • Clinique Tivoli-Ducos — Bordeaux
  • Institut Bergonie — Bordeaux
  • Polyclinique Bordeaux Nord Aquitaine — Bordeaux
  • Centre Hospitalier de Pau — Pau
  • Clinique Marzet — Pau
  • Centre Eugène Marquis — Rennes

Публикации

  • Guegan JP, Peyraud F, Dadone-Montaudie B, Teyssonneau D, Palmieri LJ, Clot E, Cousin S, Roubaud G, Cabart M, Leroy L, Lebreton C, Rey C, Lara O, Odin O, Brunet M, Vanhersecke L, Gruyters EO, Achour I, Belcaid L, Le Moulec S, Grellety T, Bessede A, Italiano A. Analysis of PD1, LAG3, TIGIT, and TIM3 expression in human lung adenocarcinoma reveals a 25-gene signature predicting immunotherapy response PMID 39591972

Идентификаторы

NCT: NCT02534649 · IB2015-09

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗