Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.

Официальное название

Prospective Validation Study of Early Cancer Biomarkers in Breath Condensate of Individuals With High-Risk of Lung Cancer Undergoing Low-Dose Computer Tomography Based Screening.

Обзор

The trial will evaluate if the newly identified biomarkers of lung cancer in exhaled breath condensate are as a diagnostic tool comparable to the low-dose computer tomography (LDCT) implemented in lung cancer screening recently. Due to the possibility to collect breath condensate at any medical workplace and due to the relatively low financial cost of examination of the collected breath condensate could improve early diagnosis of lung cancer, differential diagnostics of lung nodules and thereby reduce both the unnecessary interventions and deaths from this type of cancer.

Подробное описание

The project aims to validate newly identified biomarkers of lung cancer in breath condensate for the diagnosis and triage of lung nodules (malignant versus benign), further set the mechanisms of the functioning of the lung cancer screening center, validate the quality indicators of LDCT screening for the Czech Republic and stratify the cohort of individuals so that optimized output of screening activities. Patients aged 55-74 years with a heavy smoking load (more than 20, preferably more than 30 pack/years) will be divided into risk groups according to biomarkers in exhaled air, clinical/anamnesis data and the degree of obstructive ventilation disorder according to spirometry and subsequently there will be effective stratification of the risk of lung carcinoma. The group with the highest risk of developing lung cancer will then be diagnosed with early lung cancer using ultra-low-dose computed tomography of the chest. This will lead to early diagnosis and subsequently to a reduction in the mortality rate of the monitored active group compared to the historical cohort. The primary outcome will be the validation of the multiplex protein signature in exhaled air, the effectiveness of the screening procedure to reduce lung cancer mortality and overall mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation 60-75% with the entire group of examinees. The secondary outcome will then be the total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure. Another secondary outcome will be the costs of screening procedures for individual groups and the percentage of success of the anti-smoking intervention for the enrolled individuals. The number of newly captured interstitial lung processes will also be evaluated. Patients will be evaluated for 5 years at annual visits or earlier based on their LDCT result.

Вмешательства

• Диагностический тест Exhaled breath condensate sampling
  Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
• Диагностический тест Blood sampling
  A venous blood sample will be taken for further biomarker analysis.
• Процедура LDCT
  LDCT scan will be performed.
• Диагностический тест Vital signs
  Blood pressure, weight, height, pulse, oxygen saturation will be measured.
• Диагностический тест Spirometry
  Spirometry will be performed.

Первичные конечные точки

• Validation of the multiplex protein signature in exhaled air [Срок оценки: 5 years]
• Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules [Срок оценки: 5 years]
• Assessment of the effectiveness of the screening program [Срок оценки: 5 years]

Вторичные конечные точки (3)

• Total time of diagnosis of the nodule [Срок оценки: 5 years]
• Comparison of costs of screening procedures [Срок оценки: 5 years]
• Assessment of success of the anti-smoking intervention [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Consent to participate in a clinical trial.
• A clients within an age of 55-74 years.
• Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:

• priority will be given to clients who have smoked at least 30 pack-years.
• preference will be given to a former smoker who has not smoked for less than 15 years.

Критерии исключения

• Previous diagnosis of lung cancer.
• Progressing malignant tumor on symptomatic treatment.
• Advanced dementia
• Chronic obstructive pulmonary disease or other inflammatory disease in the phase of acute exacerbation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Чехия · 3 центра

• Masaryk Memorial Cancer Institute — Brno
• University Hospital — Olomouc
• General University Hospital in Prague — Prague

Идентификаторы

NCT: NCT06016569 · 60096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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