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Набор скоро начнётся NCT06957132

Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood

Без фазы С лечением Ototoxicity, Drug-Induced Ototoxicity, Radiation-Induced Pediatric 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: Audiogram.
Кому может быть актуально
Состояния в реестре: Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced, Pediatric Cancer. Базовые параметры: 18 лет — 50 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
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Обзор

This study is aimed at people treated for cancer before the age of 25, who have been followed for at least 5 years, and who are now aged between 18 and 50. It is a prospective, multicenter, non-randomized study. The main aim of the project is to identify hearing impaired patients using the iAudiogram medical device, and to analyze the risk factors associated with the risk of hearing impairment. Around 500 patients will take part in this study in France. Participation in this research project will consist in carrying out a hearing test (audiogram with tonal audiometry) with the iAudigram medical device (at Gustave Roussy, Curie or Necker Hospital) and completing self-questionnaires focusing on ototoxicity and its consequences.

Вмешательства

  • Устройство Audiogram
    Either the patient can be proposed to perform the audiogram during their long-term consultation, or they will be contacted by the physician to come especially for the project and realize the audiogram. iAudiogram is an Artificial Intelligence (AI) - automated audiometry platform (https://iaudiogram.com/), certified CE (European conformity). This examination will be performed once within the study.

Первичные конечные точки

  • measurement of hearing loss by frequency and/or sound level [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Patients aged between 18 and 50 years at audiological investigations
  • Treated for brain tumor, solid cancer, lymphoma or leukemia in childhood, adolescence or at a young adult age (<25years)
  • With at least 5 years of cancer-free follow-up after childhood cancer
  • Patients included in the FCCSS ( https://fccss.fr ) deep cohort of 7670 5-year childhood cancer survivors treated before 2001, or patients who have planned visit in long-term follow-up clinics of Curie Institute and Gustave Roussy, whatever the diagnostic period
  • Pregnant or breast-feeding women can be included as no risk is identified
  • With Social security coverage
  • Signed written informed consent obtained

NB: Patients included in another research project are not excluded from this one

NB: patients wearing a Lyric hearing prosthesis or any other permanent hearing prosthesis or cochlear implant can be included in the study but will not perform audiological examinations because the audiogram can't be easily performed without hearing prosthesis. Nevertheless, these patients could participate to the study with self-administered questionnaires and could be included as cases (i.e. patients with hearing deficiency) in analyses.

Критерии исключения

  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
  • Patient with unavailable data concerning treatment modalities including cumulative doses of chemotherapy agents or radiation fields and dose

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
Другое

Центры проведения

Франция · 3 центра
  • Hôpital Necker — Paris
  • Institut Curie — Paris
  • Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT06957132 · 2024-A02705-42 · 2024/3979

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗