Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection
NCT ID: NCT04315753
Last Updated: 2020-03-20
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
2018-01-01
2023-01-01
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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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.
No interventions assigned to this group
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.
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
Interventions
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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 Intervention Names
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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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Ospedale San Raffaele
OTHER
University of Paris 5 - Rene Descartes
OTHER
European Institute of Oncology
OTHER
Istituto Superiore di Sanità
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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1874
Identifier Type: -
Identifier Source: org_study_id
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