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

NCT ID: NCT04323579

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

retrospective screening cohort of 50 patients

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

No interventions assigned to this group

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%).

No interventions assigned to this group

retrospective screening cohort from the NELSON study

A retrospective screening cohort from the NELSON study.

No interventions assigned to this group

Prospective cohort of stage IV lung cancer patients

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

Medical University of Gdansk

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

University of Wuerzburg

OTHER

Sponsor Role collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulia Veronesi, MD

Role: CONTACT

02 26435278

Facility Contacts

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Federica Cioffi

Role: primary

0282247371

Other Identifiers

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2122

Identifier Type: -

Identifier Source: org_study_id

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