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
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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UNKNOWN
2000 participants
OBSERVATIONAL
2018-07-01
2021-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
* 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
* 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.
55 Years
ALL
Yes
Sponsors
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Casa Sollievo della Sofferenza IRCCS
OTHER
University of Paris 5 - Rene Descartes
OTHER
Maastricht University
OTHER
Medical University of Gdansk
OTHER
Erasmus Medical Center
OTHER
University of Wuerzburg
OTHER
Istituto Clinico Humanitas
OTHER
Responsible Party
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Locations
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Istituto Clinico Humanitas
Rozzano, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2122
Identifier Type: -
Identifier Source: org_study_id
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