Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:44 PM
Study NCT ID:
NCT07476495
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insights on Dissemination of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Check for the presence and/or levels of CTCs, ctDNA, STAS, and lymph node micrometastases in venous blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement and quantification of CTC and ctDNA', 'timeFrame': 'From enrollment to the end of study at 36 months', 'description': '* CTC (Circulating Tumor Cells) using CellSearch® (FDA-cleared) number cells per 7.5 mL of whole blood\n* ctDNA (Circulating Tumor DNA) using NGS (Illumina platform) - Variant Allele Frequency VAF (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology & Epidemiology & Lung Cancer']}, 'descriptionModule': {'briefSummary': 'In patients with resectable NSCLC treated with surgery alone or with surgery as part of a multimodal treatment; CTC, ctDNA, STAS, and lymph node micrometastasis levels will be evaluated to see if they are associated with recurrence patterns and long-term outcomes.', 'detailedDescription': 'In patients with resectable NSCLC treated with surgery alone or with surgery as part of a multimodal treatment, CTC, ctDNA, STAS, and lymph node micrometastasis levels will be evaluated to see if they are associated with recurrence patterns and long-term outcomes.\n\nTo achieve this objective, the presence and count of CTC and ctDNA will be analyzed from peripheral venous blood samples collected at three time points (before and after surgery and during follow-up). In addition, the following aspects will be evaluated as secondary objectives:\n\n1. Evaluate the consistency of spatial transcriptomics between tumor cells located in the primary lung tumor and those present in STAS and/or lymph node metastases, as well as differences in the molecular profile between primary lung tumor cells and circulating tumor cells.\n2. Quantify the impact of intraoperative variables on the release of CTCs and ctDNA into the bloodstream.\n\nThe main intraoperative variables are:\n\n* The sequence of resection of hilar structures (e.g., vein first vs. artery first).\n* Lung manipulation techniques (open surgery, VATS RATS).\n* The extent of resection (segmentectomy, lobectomy, pneumonectomy). CTCs will be analyzed using the current gold standard CTCs will be analyzed using the current gold standard platform CTC (CellSearch system, Menarini Silicon Biosystems, Italy), while ctDNA will be evaluated using Next Generation Sequencing (NGS) technology (ILLUMINA platform).\n\nFor spatial transcriptomics assessment, eosin and hematoxylin-stained slides of the primary tumor and STAS and/or lymph node metastases will be analyzed using the Xenium platform (10x Genomics, USA) to spatially quantify mRNA species with the Xenium Human Immuno-Oncology profiling panel.\n\nFor project endpoints, continuous variables will be described as median (IQR) and compared using t-tests or Mann-Whitney tests; categorical variables will be described as n (%) and compared using χ²/Fisher tests. OS and DFS will be estimated using Kaplan-Meier, compared using log-rank tests, and analyzed using multivariate Cox models (verification of proportionality assumption; results as HR and 95% CI). For the incidence of recurrence considering death as a competing event (DFI), we will use cumulative incidence functions and Gray tests; for multivariate analysis, the Fine-Gray model (sub-hazard ratio, 95% CI). Associations between biomarkers (CTC/ctDNA as continuous and/or dichotomized, e.g., CTC ≥1 cell; VAF%/ng•mL) and time-dependent outcomes will be evaluated with Cox/Fine-Gray; the probability of STAS and lymph node micrometastases with logistic regression. Pre-/post-/follow-up CTC/ctDNA dynamics will be analyzed using paired tests (Wilcoxon) and linear/mixed models with repeated measures or ANCOVA adjusting for baseline values. The effect of intraoperative variables on ΔCTC/ΔctDNA will be estimated using linear/mixed models; on the risk of recurrence/death with Cox/Fine-Gray, adjusting for age, sex, stage, histotype, grade (G3), visceral pleural invasion, PD-L1, approach (Open/VATS/RATS), extent of resection, and adjuvant therapies (with possible stratification by stage). Missing data will be treated with multiple imputation (MAR assumption) and sensitivity analyses will be performed (e.g., alternative biomarker thresholds). Significance threshold α = 0.05 two-tailed; p-values and 95% CIs will be reported; when appropriate, correction for multiple comparisons (Benjamini-Hochberg). Analysis with R/Stata/SPSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients over 18 years of age diagnosed with resectable stage cIA-cIIIA NSCLC (adenocarcinoma or squamous cell carcinoma). Fit for surgical or multimodal treatment;', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Preoperative diagnosis of resectable stage cIA-cIIIA NSCLC (adenocarcinoma or squamous cell carcinoma);\n* Patients deemed fit for surgical or multimodal treatment;\n* Informed consent obtained;\n* Treatment, including multimodal treatment, involving surgery.\n\nExclusion Criteria:\n\n* Histology other than adenocarcinoma or squamous cell carcinoma;\n* Other neoplastic diseases concurrent with or undergoing treatment or treated with systemic therapies in the previous three years;\n* Age \\<18 years;\n* No need for surgery.'}, 'identificationModule': {'nctId': 'NCT07476495', 'acronym': 'LUCID', 'briefTitle': 'Insights on Dissemination of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Insights on Dissemination of Lung Cancer', 'orgStudyIdInfo': {'id': 'LUCID'}, 'secondaryIdInfos': [{'id': 'GR-2024-12379380', 'type': 'OTHER_GRANT', 'domain': 'Ministero della Salute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Bertoglio, MD', 'role': 'CONTACT', 'email': 'pietro.bertoglio@aosp.bo.it', 'phone': '+39 0516478362'}], 'facility': 'IRCCS Azienda Ospedaliero-Università di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Pietro Bertoglio', 'role': 'CONTACT', 'email': 'pietro.bertoglio@aosp.bo.it', 'phone': '+39 0516478362'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}