Clinical trial NCT04315753: Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection
Official title: Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Biomarkers
Circulating tumor cells
Screening
Computer Tomography (CT Scan)
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Ospedale San Raffaele
name: University of Paris 5 - Rene Descartes
name: European Institute of Oncology
name: Istituto Superiore di Sanità
First posted: 2020-03-20
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: Validation of biomolecular markers in the circulation and radiomic features are the focus of this project.The aim is to assess the role of molecular and cellular biomarkers (exosomes antigens, Circulating tumor cells - CTCs, panel of mutations in circulating free DNA) and radiomic signature, as complementary to assist early detection of lung cancer by LDCT.


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: Obtaining biological samples, and correspondent clinical and imaging data to use, as fresh blood tissues or frozen stored tissues from lung cancer patients and controls obtained from the Division of Thoracic Surgery and LDCT lung-cancer screening program
timeFrame: 01 Jan 2018 - 01 Jan 2023
Secondary outcomes:
measure: Tumor antigens identified by RPPA in lung cancer circulating exosome
timeFrame: 01 Jan 2018 - 01 Jan 2023
measure: Investigate the potential role of CTCs as diagnostic and prognostic tool in a screening content
timeFrame: 01 Jan 2018 - 01 Jan 2023
measure: Development and validation of a panel of mutations on circulating DNA as diagnostic test for lung cancer.
timeFrame: 01 Jan 2018 - 01 Jan 2023
measure: Investigate a radiomic signature to discriminate malignant lung nodule Background
timeFrame: 01 Jan 2018 - 01 Jan 2023
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: