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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
Sponsor:
Collaborators:
Ospedale San Raffaele
University of Paris 5 - Rene Descartes
European Institute of Oncology
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment
Lung Cancer Other: LDCT (Low Dose CT)

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other Names:
  • Molecular biomarkers
  • Cellular biomarkers




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Giulia Veronesi, MD 02 26435278 veronesi.giulia@hsr.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Federica Cioffi    0282247371    federica.cioffi@humanitas.it   
Sponsors and Collaborators
Istituto Clinico Humanitas
Ospedale San Raffaele
University of Paris 5 - Rene Descartes
European Institute of Oncology
Istituto Superiore di Sanità

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04315753    
Other Study ID Numbers: 1874
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Clinico Humanitas:
Biomarkers
Circulating tumor cells
Screening
Computer Tomography (CT Scan)
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases