Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection

Lung Cancer Clinical Trial

— SMAC-2  

Official title:

Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315753
• Other study ID #: 1874
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2020
• Source: Istituto Clinico Humanitas
• Contact: Giulia Veronesi, MD
• Phone: 02 26435278
• Email: veronesi.giulia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• LDCT (Low Dose CT)
validate the role of non-invasive molecular and cellular biomarkers and combined radiomic signature, as complementary tools to assist early detection of lung cancer by LDCT using bioinformatic techniques for the integration of the results

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (5)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	European Institute of Oncology, Istituto Superiore di Sanità, Ospedale San Raffaele, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1.1 : Obtaining biological material from cancer cases and controls (clinical cases) and store in the biobank with clinical data and imaging for bio radiomic analysis.; 1.2 : Identification and testing of methods of recruiting high-risk individuals for a lung-cancer screening program using available database to select very high risk individuals; 1.3 : Obtaining biological material from asymptomatic screening-detected cancer cases and controls and store in the biobank with clinical data and imaging.; 1.4 : Assessment of compliance of the recruited population and assessment of mean lung-cancer risk. Verify the potential impact of molecular markers as a pre-screening test to better assess the risk of subjects, evaluate the impact on nodule management and number of false positive cases among screening process according to biostatistical analysis.	01 Jan 2018 - 01 Jan 2023
Secondary	Tumor antigens identified by RPPA in lung cancer circulating exosome	Blood-derived exosomes will be collected. Exosome antigens assessment will be performed. Then, a bioinformatics analysis of the performance of exosome antigens as diagnostic markers for lung cancer will be performed.	01 Jan 2018 - 01 Jan 2023
Secondary	Investigate the potential role of CTCs as diagnostic and prognostic tool in a screening content	3.1 Samples collection and preparation: isolation and count of CTCs; 3.2 Evaluation of diagnostic role of CTCs in early stage lung cancers; 3.3 Evaluation of the prognostic value of the number of CTCs at diagnosis (measured in terms of "progression free survival" and "overall survival"); 3.4 Characterization of CTCs for the expression of EMT and correlation with angiogenesis pattern of primary tumor; 3.5 Biostatistical analysis of the results.	01 Jan 2018 - 01 Jan 2023
Secondary	Development and validation of a panel of mutations on circulating DNA as diagnostic test for lung cancer.	4.1 Samples collection and library preparation; 4.2 Standardisation of the technique; 4.3 Assessment of diagnostic role of the protein signature; 4.4 Bioinformatics analysis of the performance of the cell free DNA mutation signature as diagnostic tool for lung cancer	01 Jan 2018 - 01 Jan 2023
Secondary	Investigate a radiomic signature to discriminate malignant lung nodule Background	5.1 assess the association of imaging features with clinical data and histology; 5.2 Identification the radiomic signature, the combination of imaging features, able to characterize lung lesions; 5.3 Validation of the signature on a new subset of patients; 5.4 Assessment of the role of radiomic signature, together with circulating markers in predicting lung malignancy	01 Jan 2018 - 01 Jan 2023