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

NCT04315753 | Unknown

• 1 other identifier: 1874
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Biomarkers; Circulating tumor cells; Screening; Computer Tomography (CT Scan)

Outcome Measures

Primary Outcomes (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

  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 Outcomes (4)

• Tumor antigens identified by RPPA in lung cancer circulating exosome

  01 Jan 2018 - 01 Jan 2023

• Investigate the potential role of CTCs as diagnostic and prognostic tool in a screening content

  01 Jan 2018 - 01 Jan 2023

• Development and validation of a panel of mutations on circulating DNA as diagnostic test for lung cancer.

  01 Jan 2018 - 01 Jan 2023

• Investigate a radiomic signature to discriminate malignant lung nodule Background

  01 Jan 2018 - 01 Jan 2023

Study Arms (2)

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)

Interventions

LDCT (Low Dose CT) OTHER

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

Also known as: Molecular biomarkers, Cellular biomarkers

prospective screening cohort of high risk individuals

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Ospedale San Raffaele: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• European Institute of Oncology: collaborator
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giulia Veronesi, MD

CONTACT

02 26435278; veronesi.giulia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: March 20, 2020
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)