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Набор скоро начнётся NCT07279948

Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)

— Наблюдательное 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 50 лет — 80 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
Бразилия
Следующий шаг
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Обзор

A prospective, longitudinal, single-arm interventional study of lung cancer screening.

Подробное описание

Main hypothesis: The tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease could leads to an increase in the proportion of false-positive cases resulting in unnecessary medical procedures, which represents a waste of resources and a risk for patients.

Main objective: To assess whether the percentage of false-positive cases with indication of biopsy after lung cancer screening with low-dose CT in high-risk smokers in a population with a high prevalence of granulomatous disease will be within the expected range according to other studies in the literature.

As there is robust evidence of the effectiveness of screening in reducing mortality from lung cancer, we expect the project to bring benefits to patients treated for image-detected lung cancer in the project, with reduced staging and a shorter time between diagnosis and treatment. Therefore , although the focus is on the safety of screening, the project will also monitor the cancer detection rate, which is a surrogate endpoint of effectiveness.

Первичные конечные точки

  • • Proportion of negative cases on screening according to the Lung-RADS classification. [Срок оценки: Last 10 years]
  • • Proportion of false-positives. [Срок оценки: Last 10 years]
Вторичные конечные точки (7)
  • • Cancer detection rate. [Срок оценки: last 10 years]
  • • Willingness to be screened (ie, proportion of eligible patients actually signing up for the study) [Срок оценки: Last 10 years]
  • • Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator). [Срок оценки: Last 10 years]
  • • Percentage of adherence to follow-up. [Срок оценки: Last 10 years]
  • • Prevalence of granulomatous disease in screening positive cases [Срок оценки: Last 10 years]
  • • Prevalence of incidental findings. [Срок оценки: Last 10 years]
  • • Prevalence of clinically relevant incidental findings that required follow-up. [Срок оценки: Last 10 years]

Критерии участия

Критерии включения

In order, to be eligible for the study, patients must fulfill all the following inclusion criteria:

  • Age between ≥50 and ≤80 years.
  • Be a current smoker or have quit 15 years ago or less.
  • Have participated or are currently participating in smoking cessation program.
  • Lifetime smoking exposure equal to or greater than 20 pack-year.
  • Provided signed informed consent (ICF)

Критерии исключения

  • In order, to be exclude for the study, patients must at least one of the following exclusion criteria:
  • Contraindications to the screening examination: (claustrophobic or weighing more than 130 kgs).
  • Inability to climb 3 stair steps non-stop (36 steps).
  • Disabling dyspnea
  • Symptomatic (with signs and symptoms suspicious of breast cancer lung, namely):
  • pleuritic chest pain
  • rapidly progressive dyspnea of recent onset
  • hemoptysis
  • unexplained hoarseness, lasting more than 1 month.
  • bone pain
  • supraclavicular lymphadenopathy or cervical lymphadenopathy persistent
  • unexplained weight loss of 5% or more of weight in less than 6 months
  • Previous history of malignant neoplasm (excluding non-melanoma skin cancer) diagnosed less than 10 years before the date of the interview;
  • Patients with diagnostic of severe psychiatric disease
  • Immunosuppressed by illness or drugs.
  • Subjected to anterior lung resection even when determined due to an etiology other than malignant neoplasia.
  • Person with a serious terminal illness that contraindicates curative lung surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Бразилия · 1 центр
  • Research Site — Rio de Janeiro

Идентификаторы

NCT: NCT07279948 · D133FR00225

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗