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Идёт набор NCT07465848

Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis

Без фазы С лечением Lung Cancer (Diagnosis) Health Adult Subjects Patient

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: Blood sample collection for telomere biomarker analysis, Telomere biomarker analysis.
Кому может быть актуально
Состояния в реестре: Lung Cancer (Diagnosis), Health Adult Subjects, Patient. Базовые параметры: от 45 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
Испания
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 research is a clinical performance study of in vitro diagnostic device (IVD), a prospective, multicentre, open-label, case-control clinical investigation aimed at constructing a predictive model that allows results to be classified as positive or negative in relation to the probability of having lung cancer.

Вмешательства

  • Диагностический тест Blood sample collection for telomere biomarker analysis
    Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.
  • Диагностический тест Telomere biomarker analysis
    Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.

Первичные конечные точки

  • To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer. [Срок оценки: At study enrollment]
Вторичные конечные точки (1)
  • To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls. [Срок оценки: At study enrollment]

Критерии участия

Критерии включения

Case Group:

  • Person aged 45 years or older at the time of signing the consent form.
  • Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
  • Not having received any oncological treatment prior to sample collection (surgery, radiotherapy, or systemic treatment with chemotherapy or immunotherapy).

Control Group:

Cohort A (High risk controls):

  • Person aged 45 years or older at the time of signing the consent form.
  • High risk of lung cancer, defined as having a smoking history of at least 20 pack-year and currently smoking or having quit within the past 15 years.
  • No diagnosis or suspicion of lung cancer. Asymptomatic individuals who have undergone a chest computed tomography (CT) scan for lung cancer screening within the 12 months prior to signing the informed consent and as part of routine clinical practice, with a LUNG-RADS score of 3 or lower, will be included.

Cohort B (Low-risk controls):

  • Person aged 45 years or older at the time of signing the consent form.
  • Without high risk of lung cancer according to the criteria defined in cohort A.
  • No diagnosis or suspicion of lung cancer.

Критерии исключения

  • History of any malignant neoplasm, except for subjects with tumors in localized stages who have undergone radical treatment and have been disease-free for at least five years.
  • Patient diagnosed with lung cancer who has already started oncological treatment before sample collection.
  • Patient who has undergone a biopsy or any invasive procedure or minor surgery less than 48 hours ago.
  • Patient who has undergone major surgery less than 7 days ago.
  • Patient with severe chronic kidney disease, defined as a glomerular filtration rate below 15 ml/min.
  • Patient with severe liver disease, defined as Child-Pugh C.
  • Active infection, or treated less than 4 weeks ago.
  • Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Испания · 12 центров
  • Hospital General Universitario de Elche — Elche
  • Hospital del Mar — Barcelona
  • Institut Catalá D'Oncologia Badalona (ICO) — Barcelona
  • Hospital Universitario Marqués de Valdecilla — Santander
  • Clínica Universidad de Navarra — Madrid
  • HM Sanchinarro/CIOCC — Madrid
  • Hospital Universitario 12 Octubre — Madrid
  • Hospital Universitario Clínico San Carlos — Madrid
  • … и ещё 4 центра

Идентификаторы

NCT: NCT07465848 · PneumoTAV001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗