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Набор скоро начнётся NCT07511569

Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN)

— Наблюдательное Chemotherapy Induced Neuropathic Pain Neuropathy Toxic Taxane-induced Peripheral Neuropathy Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

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: longitudinal blood sampling and standardized neurological evaluation over 6 months.
Кому может быть актуально
Состояния в реестре: Chemotherapy Induced Neuropathic Pain, Neuropathy Toxic, Taxane-induced Peripheral Neuropathy, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients. Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months is to identify biomarkers to predict the overall occurrence of chronic chemotherapy-induced peripheral neuropathy (CIPN, any grade), in each of two treatment subgroups (taxanes and oxaliplatin). It involves integration of clinical data and plasma multiomic biomarkers (proteomic + metabolomic panel) analyzed via supervised machine learning to identify predictive features of CIPN.

Подробное описание

In this prospective exploratory cohort study based on artificial intelligence data analysis, we aim to identify useful markers to predict the occurrence of CIPN in patients receiving taxanes or oxaliplatin to treat their cancers.

We plan to recruit 192 consecutive patients from 2 hospitals (Hôpital Forcilles and Centre Hospitalier de Bligny) treated for cancer, aimed to receive a prolonged treatment (9 weeks or more) with a neurotoxic drug: taxanes (subgroup 1: 78 patients), and oxaliplatin (subgroup 2: 114 patients). Study design is built to detect promising markers (including biomarkers from our exclusive panel) possibly linked to neuropathy that could help predict its occurrence and clinically meaningful impact. A balanced selection was made to enable the collection of as much information as possible while limiting the impact on patients. Patients will be included before treatment and follow-up will last 6 months after start of treatment.

Вмешательства

  • Диагностический тест longitudinal blood sampling and standardized neurological evaluation over 6 months
    Prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months

Первичные конечные точки

  • Neuropathy prediction [Срок оценки: From enrollment to 6 months after.]
Вторичные конечные точки (2)
  • Neuropathy severity prediction [Срок оценки: From enrollment to 6 months after]
  • Time to onset of chronic neuropathy [Срок оценки: from enrollment to 6 months after]

Критерии участия

Критерии включения

  • Patients who have received detailed information about the study and have signed, with the investigator, a consent form to participate in the study
  • Patients being treated for cancer at any stage of the disease and scheduled to receive chemotherapy including one (and only one) of the following molecules: paclitaxel, docetaxel, or oxaliplatin, for a planned duration of 9 weeks or more
  • Age > 18 years
  • Life expectancy > 3 months
  • Patient affiliated with or entitled to social security

Критерии исключения

  • Patients already suffering from neuropathy or chronic neurogenic pain
  • Patients with type 1 or type 2 diabetes (for more than 10 years for type 2 diabetes)
  • Patients who have already received neurotoxic cancer treatment including those in clinical trials
  • Patients receiving two of the study molecules simultaneously (only one study molecule is permitted, including in combination chemotherapy but that does not include another neurotoxic molecule)
  • Patients receiving immunotherapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07511569 · 2026-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗