Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection (SMAC-2)

Istituto Clinico Humanitas

Status: Unknown

Conditions: Lung Cancer

Treatments: Other: LDCT (Low Dose CT)

Study type: Observational

Funder types: Other

Identifiers

NCT04315753

1874

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

cancer patients (clinical stage I and II) +controls

Description:

70 lung cancer patients (clinical stage I and II) diagnosed outside screening and candidates to surgical resection at Humanitas Hospital, and 70 controls with benign nodules. Cancer patients will undergo blood collection before and at 4 months after surgical resection. Blood will be used for CTC analysis, exosome antigens and circulating free DNA (cfDNA) mutational analysis.

prospective screening cohort of high risk individuals

Description:

a prospective screening cohort of high risk individuals enrolled at Humanitas Hospital (1000) will allow to recruit 50 patients with screening detected lung cancer and a large number of negative controls. Analysis of CTC, exosome antigens and cfDNA mutation profile will be performed.

Treatment:

Other: LDCT (Low Dose CT)