Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.

NCT04323579 | Unknown DMC

• 1 other identifier: 2122
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and radiomic signature, as complementary to assist early detection of lung cancer by low dose computed tomography-LDCT, using bioinformatics techniques; (b) assess the prognostic role of CTCs including the role of cells epithelial mesenchymal transition (EMT) and (c) standardize a method for genomic analysis of CTCs for early detection of treatment resistance.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Validation of the role of a bio-radiomic protocol as complementary tool to assist early detection of lung cancer by LDCT

  CTC analysis will be performed using fresh plasma samples. Blood collection will be obtained for each lung cancer patient before and after surgery and once for controls. 45- and 16-miRNA signatures will be analyzed on plasma samples of the retrospective cohort (150 lung cancer patients and 120 matched controls). We will perform the exosome antigens analysis in the retrospective cohort. We will validate the 8-protein signature in the retrospective cohort. We will validate the radiomic signature on CT images, and further validation will be performed on CT images of the prospective cohorts collected and 70 screened individuals of the retrospective cohort. We will integrate results of biomarkers and radiomic data and will build a multiparametric risk model to improve early detection of lung cancer. The final predictive model will be then applied to the cohorts analysed and integrated with LDCT results to evaluate the improvement in diagnostic accuracy.

  01 July 2018 - 01 July 2021

Secondary Outcomes (3)

• Correlation of CTC spread to angiogenesis.

  01 July 2018 - 01 July 2021

• Assessment of epithelial mesenchymal transition (EMT) in CTC as a hallmark of poor prognosis.

  01 July 2018 - 01 July 2021

• Standardise a method for genomic analysis from isolated CTCs for the early detection of resistance to treatments

  01 July 2018 - 01 July 2021

Study Arms (5)

prospective cohort of stage I-II lung cancer patients

A prospective cohort of stage I-II lung cancer patients (N=80) candidates to surgery at Humanitas, and 40 controls with benign nodules.

retrospective screening cohort of 50 patients

A retrospective screening cohort of 50 patients with screened lung cancer at MUG.

prospective screening cohort of 30 patients

A prospective screening cohort of 30 patients with screened lung cancer and 100 matched negative controls enrolled at Humanitas cohort of 1000 participants (expected annual rate 1.5%).

retrospective screening cohort from the NELSON study

A retrospective screening cohort from the NELSON study.

Prospective cohort of stage IV lung cancer patients

A Prospective cohort of stage IV lung cancer patients (N=30) candidate to systemic therapy.

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
• Casa Sollievo della Sofferenza IRCCS: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• Maastricht University: collaborator
• Medical University of Gdansk: collaborator
• Erasmus Medical Center: collaborator
• University of Wuerzburg: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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 26, 2020
• Study Start: July 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

IT (1)