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Идёт набор NCT05257967

CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease

Без фазы С лечением EGFR Activating Mutation Leptomeningeal Metastasis Non Small Cell Lung Cancer

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: Lumbar puncture and Phlebotomy.
Кому может быть актуально
Состояния в реестре: EGFR Activating Mutation, Leptomeningeal Metastasis, Non Small Cell Lung Cancer. 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
Канада
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

CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer

Обзор

Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC. Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.

Подробное описание

The aim of this pilot trial is to evaluate the concordance/discordance of molecular profiling of CSF and plasma ctDNA after the development of leptomeningeal disease in EGFR mutant NSCLC. Patients with EGFR mutant NSCLC who develop leptomeningeal disease on a first, second or third generation tyrosine kinase inhibitor are potentially eligible for this clinical trial.

This is a prospective pilot study designed to accrue 10 patients. Baseline MRI brain and spine must be completed prior to enrolment to insure that a lumbar puncture can be completed safely. All eligible subjects will be consented for ddPCR and Canexia Follow It plasma and CSF based molecular testing. Patients will have baseline information collected and will complete baseline quality of life (QoL) questionnaires. QoL questionnaires will be obtained every 12 weeks +/- 2 weeks and survival will be measured through chart review. There will be no treatment intervention; however we will collect information on treatment received after enrolment in trial. Volume of leptomeningeal disease will be scored by number of gadolinium enhancing sites in 8 predetermined locations.

Вмешательства

  • Диагностический тест Lumbar puncture and Phlebotomy
    Sampling of cerebral spinal fluid and plasma.

Первичные конечные точки

  • Concordance of molecular profiling of CSF and plasma in EGFR mutation positive NSCLC patients with leptomeningeal disease [Срок оценки: 36 months]
Вторичные конечные точки (6)
  • Concordance of treatment recommendations based on ctDNA and CSF [Срок оценки: 36 months]
  • Molecular profiling comparison [Срок оценки: 36 months]
  • Molecular profiling descriptive comparison of patients treated with first/second generation versus 3rd generation EGFR TKIs [Срок оценки: 36 months]
  • Correlation between MRI and CSF [Срок оценки: 36 months]
  • Overall survival [Срок оценки: 36 months]
  • Quality of life with leptomeningeal disease [Срок оценки: 36 months]

Критерии участия

Критерии включения

  • Subject age is greater than or equal to 18 years at the time of signature of informed consent.
  • Histologically or cytologically confirmed metastatic EGFR mutant NSCLC.
  • Leptomeningeal disease based on brain MRI or CSF cytology.
  • ECOG 0-3.
  • Life expectancy of at least 8 weeks.
  • Adequate hematologic and end organ function for testing.
  • Ability to give informed consent for the study procedures defined in this protocol.

Критерии исключения

  • Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
  • Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
  • MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.

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

Канада · 1 центр
  • BC Cancer — Vancouver

Публикации

  • White MD, Klein RH, Shaw B, Kim A, Subramanian M, Mora JL, Giobbie-Hurder A, Nagabhushan D, Jain A, Singh M, Kuter BM, Nayyar N, Bertalan MS, Stocking JH, Markson SC, Lastrapes M, Alvarez-Breckenridge C, Cahill DP, Gydush G, Rhoades J, Rotem D, Adalsteinsson VA, Mahar M, Kaplan A, Oh K, Sullivan RJ, Gerstner E, Carter SL, Brastianos PK. Detection of Leptomeningeal Disease Using Cell-Free DNA From PMID 34369989
  • Nevel KS, DiStefano N, Lin X, Skakodub A, Ogilvie SQ, Reiner AS, Pentsova E, Boire A. A retrospective, quantitative assessment of disease burden in patients with leptomeningeal metastases from non-small-cell lung cancer. Neuro Oncol. 2020 May 15;22(5):675-683. doi: 10.1093/neuonc/noz208. PMID 32352148

Идентификаторы

NCT: NCT05257967 · LUEGFRLM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗