Clinical trial NCT04323579: Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.
Official title: Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Casa Sollievo della Sofferenza IRCCS
name: University of Paris 5 - Rene Descartes
name: Maastricht University
name: Medical University of Gdansk
name: Erasmus Medical Center
name: University of Wuerzburg
First posted: 2020-03-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population should have the following inclusion criteria: Inclusion Criteria: - Age ≥ 55 years old and exposure to smoking more than 30 packsyear; 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.

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 of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and radiomic signature, as complementary to assist early detection of lung cancer by low dose computed tomography-LDCT, using bioinformatics techniques; (b) assess the prognostic role of CTCs including the role of cells epithelial mesenchymal transition (EMT) and (c) standardize a method for genomic analysis of CTCs for early detection of treatment resistance.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Validation of the role of a bio-radiomic protocol as complementary tool to assist early detection of lung cancer by LDCT
timeFrame: 01 July 2018 - 01 July 2021
Secondary outcomes:
measure: Correlation of CTC spread to angiogenesis.
timeFrame: 01 July 2018 - 01 July 2021
measure: Assessment of epithelial mesenchymal transition (EMT) in CTC as a hallmark of poor prognosis.
timeFrame: 01 July 2018 - 01 July 2021
measure: Standardise a method for genomic analysis from isolated CTCs for the early detection of resistance to treatments
timeFrame: 01 July 2018 - 01 July 2021
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: