Status:
UNKNOWN
Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Casa Sollievo della Sofferenza IRCCS
University of Paris 5 - Rene Descartes
Conditions:
Lung Cancer
Eligibility:
All Genders
55+ years
Brief Summary
CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role ...
Eligibility Criteria
Inclusion
- Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Exclusion
- Previous diagnosis of lung cancer.
- Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
- Performing a chest CT scan in the last 18 months.
- Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04323579
Start Date
July 1 2018
End Date
July 1 2021
Last Update
March 26 2020
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089