Clinical trial · Observational
Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection
NCT04315753CI-TRIAL-00044155SMAC-2unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDCT (Low Dose CT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- cancer patients (clinical stage I and II) +controls
- description
- 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.
- label
- prospective screening cohort of high risk individuals
- description
- 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.
- interventionNames
- Other: LDCT (Low Dose CT)
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.