Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection (SMAC-2)
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|ClinicalTrials.gov Identifier: NCT04315753|
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment|
|Lung Cancer||Other: LDCT (Low Dose CT)|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
cancer patients (clinical stage I and II) +controls
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
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.
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
- 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 [ Time Frame: 01 Jan 2018 - 01 Jan 2023 ]
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.
- Tumor antigens identified by RPPA in lung cancer circulating exosome [ Time Frame: 01 Jan 2018 - 01 Jan 2023 ]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.
- Investigate the potential role of CTCs as diagnostic and prognostic tool in a screening content [ Time Frame: 01 Jan 2018 - 01 Jan 2023 ]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.
- Development and validation of a panel of mutations on circulating DNA as diagnostic test for lung cancer. [ Time Frame: 01 Jan 2018 - 01 Jan 2023 ]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
- Investigate a radiomic signature to discriminate malignant lung nodule Background [ Time Frame: 01 Jan 2018 - 01 Jan 2023 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315753
|Contact: Giulia Veronesi, MD||02 email@example.com|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano, Milano, Italy, 20089|
|Contact: Federica Cioffi 0282247371 firstname.lastname@example.org|