[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regina Elena Cancer Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":562},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,54,73,91,112,130,150,171,189,208,228,261,283,306,326,345,363,387,408,429,447,471,493,514,541],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100642296","impact-of-liquid-biopsy-on-the-therapeutic-pathway-for-lung-cancer-advancing-the-molecular-characterization-of-patients-with-advanced-lung-adenocarcinoma-by-integrating-liquid-biopsy-into-the-early-stages-of-the-diagnostic-and-therapeutic-pathway-100642296",false,"NCT07649629","Impact of Liquid Biopsy on the Therapeutic Pathway for Lung Cancer: Advancing the Molecular Characterization of Patients With Advanced Lung Adenocarcinoma by Integrating Liquid Biopsy Into the Early Stages of the Diagnostic and Therapeutic Pathway","Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico","INNOVA-LUNG","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n* Tissue biopsy and\u002For cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).\n* Written informed consent for study participation and personal data processing obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* Previous or current history of non-small cell lung cancer (NSCLC).\n* Histopathological diagnosis of NSCLC already available following tissue biopsy.\n* Eligibility for surgical removal of tumor tissue.\n* Ongoing or previous systemic oncological treatment for lung cancer.","ALL","18 Years",{"count":21,"type":22},70,"ESTIMATED","OBSERVATIONAL","This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC).\n\nLiquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue.\n\nApproximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated.\n\nThe results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.",[26],"Advanced Non-small Cell Lung Cancer (NSCLC)",[28,29,30,31,32,33,34,35,36,37,38,39,40],"Lung Cancer","Liquid biopsy","Plasma-first approach","Non-small cell lung cancer","NSCLC","ctDNA","ctRNA","NGS","Molecular profiling","Tumor fraction","Actionable genomic alterations","Targeted therapy","Biomarkers","RECRUITING","2026-06-10",{"date":44,"type":45},"2026-06-16","ACTUAL",{"date":47,"type":45},"2025-09-01",{"date":49,"type":22},"2027-03-01",{"name":51,"class":52},"Regina Elena Cancer Institute","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":53},"100643235","immune-metabolism-dysregulation-and-efficacy-to-anti-pd-1-pd-l1-agents-in-non-small-cell-lung-cancer-patients-100643235","NCT07637474","Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of advanced stage NSCLC\n* Histotype adenocarcinoma and squamous carcinoma\n* ECOG PS \\\u003C2\n* Known PDL-1 stage\n* Measurable disease\n* Availability of tumor tissue\n* No evidence of molecular drivers\n* Written informed consent (to the study and data processing)\n\nFor the second cohort in addition to the precedents it is included\n\n* Diagnosis of limited or locally advanced NSCLC deemed resectable\n\nFor the third cohort in addition to the precedents it is included\n\n* patients candidates for surgery for non-small cell lung cancer\n\nExclusion Criteria:\n\n* Contraindications to immunotherapy\n* Unavailability of tumor tissue\n* Histotype with neuroendocrine or mixed component\n\nFor the second cohort\n\n* Contraindication to immunotherapy\n* Histotype with neuroendocrine or mixed component\n* Locally advanced disease candidate for concomitant chemo-radiotherapy treatment\n\nFor the third cohort\n\n* previously treated patients",{"count":61,"type":22},150,"Prospective, biological, observational study involving the collection and use of samples from patients suffering from NSCLC lung cancer, aimed at comparing the molecular profile related to metabolism among subjects with response or resistance to checkpoint inhibitors immune system (ICI), in order to contribute to define response biomarkers and new molecular pathways as therapeutic targets combine with ICI to overcome resistance.",[64],"Nsclc","2026-06-04",{"date":67,"type":45},"2026-06-09",{"date":69,"type":45},"2024-07-24",{"date":71,"type":22},"2026-07-24",{"name":51,"class":52},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":90,"locationsCount":53},"100639992","standardization-of-a-platform-of-preclinical-models-derived-from-nsclc-patients-100639992","NCT07629375","Standardization of a Platform of Preclinical Models Derived From NSCLC Patients","Standardization of a Platform of Preclinical Models Derived From NSCLC Patients to Investigate the Efficacy of New Nutraceutical Compounds Used as Monotherapy or in Combination With Immunotherapeutics or Chemo-immunotherapy","Inclusion criteria:\n\n* Patients over 18 years of age;\n* Patients diagnosed with resectable NSCLC who will undergo curative surgery;\n* Patients who give written informed consent (study participation and data processing).\n\nExclusion criteria:\n\n* Previous malignancies;\n* Previous systemic treatments.",{"count":81,"type":22},5,"Characterize and trace innovative nutraceuticals based on microencapsulated resveratrol and Cynara cardunculus extract, using preclinical models such as organotypic tissue slices and tumoroids created from tumor fragments derived from patients with non-small cell lung cancer. This will enable the development of combination therapies to increase the efficacy of immunotherapy in NSCLC and reduce side effects that lead to treatment discontinuation.\n\nThe market implementation of these products may offer unique advantages, including increased clinical efficacy, improved tolerability of immune checkpoint inhibitors, reduced healthcare costs, improved quality of life for patients and their families, traceability of naturally derived products, and environmental sustainability.",[84],"Non-Small Cell Lung Cancer",{"date":86,"type":45},"2026-06-05",{"date":88,"type":45},"2025-07-24",{"date":71,"type":22},{"name":51,"class":52},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":53},"100594330","role-of-ttv-during-first-line-immunotherapy-treatment-in-patients-with-renal-cell-carcinoma-100594330","NCT07018037","Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma","Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma","TTV ccRCC","Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Histological diagnosis of clear cell renal cell carcinoma;\n* Evidence of advanced or metastatic disease;\n* Patients diagnosed with metastatic clear cell renal cell carcinoma about to start first-line immunotherapy (ICI + ICI or ICI + TKI);\n* Patients able to comply with the study procedures.\n* Patients who give written informed consent personally or through a witness (study participation and data processing), before any study-specific procedure is started.\n\nExclusion Criteria:\n\n* Previous neoplasms;\n* Previous antineoplastic treatments;\n* Previous steroid treatments;\n* Active viral infections (e.g., HCV, HIV, etc.);\n* Lack of autonomy in adhering to study procedures.",{"count":100,"type":22},20,"The aim of this project is to descriptively explore the trend of torquetenovirus viral load TTV during therapy with immune checkpoint inhibitor ICI in these patients, to evaluate a possible role of this virus as a biomarker of response.",[103],"Renal Cell Carcinoma",[105],"Torquetenovirus (TVV)",{"date":86,"type":45},{"date":108,"type":45},"2025-01-29",{"date":110,"type":22},"2027-01-29",{"name":51,"class":52},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":53},"100583967","three-mirna-signatures-in-glioma-from-molecular-mechanisms-to-potential-clinical-application-100583967","NCT06883214","Three miRNA Signatures in Glioma: From Molecular Mechanisms to Potential Clinical Application","Deciphering the Functional Role of a Three-miRNA Signature in Glioma: From Molecular Mechanisms to Potential Clinical Application","Inclusion Criteria:\n\n* histological diagnosis of glioma;\n* no concomitant primary tumor;\n* no metastatic disease;\n* availability of surgical material\u002Ftissue;\n* written informed consent.\n\nExclusion Criteria:\n\n* histological diagnosis of non-glial tumor;\n* patients with concomitant other solid tumors;\n* metastatic disease;\n* no surgical material\u002Ftissue available;\n* HIV seropositivity.",{"count":120,"type":22},10,"Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. Therefore, ectopic expression of the miRNAs identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.",[123],"Glioma",{"date":86,"type":45},{"date":126,"type":45},"2023-01-17",{"date":128,"type":22},"2027-01-17",{"name":51,"class":52},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":149,"locationsCount":53},"100579203","patients-with-human-papillomavirus-associated-head-and-neck-cancer-for-the-discovery-of-predictive-biomarkers-to-guide-clinical-intervention-100579203","NCT06821243","Patients With Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention","Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention","Inclusion Criteria:\n\n* Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical\n* Age \\> 18 years\n* ECOG performance status \\\u003C\\_ 2\n* Signature of informed consent (to participate in the study and data processing)\n\nExclusion Criteria:\n\n* Presence of distant metastases at the time of diagnosis\n* Previous head and neck cancer",{"count":138,"type":22},40,"Prospective pilot study, non-interventional, of a biological\u002Fradiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA\u002FRNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response",[141],"Squamous Cell Carcinoma of Oropharynx",[143,144,145],"carcinoma of the oropharynx","squamous cell carcinoma of the oropharynx","head and neck",{"date":86,"type":45},{"date":69,"type":45},{"date":71,"type":22},{"name":51,"class":52},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":53},"100575379","phase-2-association-of-thoraco-mediastinal-radiotherapy-with-maintenance-immunotherapy-treatment-with-atezolizumab-100575379","NCT06771518","Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab","Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab","Inclusion Criteria:\n\n* Histological diagnosis of lung microcytoma;\n* Age ≥18 years;\n* Performance status according to ECOG 0-2;\n* Extended disease at the time of first line oncological treatment;\n* Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;\n* In at least partial response (defined according to the Recist criteria \\[18\\]) after treatment chemoimmunotherapy according to the Impower 133 scheme;\n* Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;\n* Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or \\>40%, DLCO≥50%;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Previous radiotherapy treatment at the thoraco-mediastinal level;\n* In disease progression after chemo-immunotherapy treatment.",{"count":158,"type":22},37,"INTERVENTIONAL",[161],"PHASE2","Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.",[164],"Small Cell Lung Cancer",{"date":86,"type":45},{"date":167,"type":45},"2021-12-15",{"date":169,"type":22},"2026-12-15",{"name":51,"class":52},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":188,"locationsCount":53},"100534543","biomarkers-of-efficacy-and-tolerability-of-sacituzumab-govitecan-in-the-treatment-of-patients-with-triple-negative-breast-cancer-in-the-metastatic-phase-prospective-multicenter-real-world-study-100534543","NCT06240195","Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study","BIO-PROSA","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histological diagnosis of TNBC;\n* Locally advanced unresectable or metastatic disease;\n* Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);\n* Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);\n* Written informed consent;\n* Availability to comply with the procedures established by the protocol, according to the methods and times described.\n\nExclusion Criteria:\n\n* Patients with a history of other malignancies;\n* Contraindications to the use of sacituzumab govitecan SG;\n* Untreated and\u002For clinically unstable (symptomatic) brain metastases.","FEMALE",{"count":180,"type":22},60,"Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy\u002Ftolerability carried out on multiple platforms at the center coordinator.",[183],"Breast Cancer",{"date":86,"type":45},{"date":126,"type":45},{"date":187,"type":22},"2027-06-17",{"name":51,"class":52},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":53},"100538146","the-role-of-the-freepedunculated-flap-in-total-laryngectomy-after-chemo-radiotherapy-failure-for-laryngeal-carcinoma-impact-on-the-risk-of-pharyngocutaneous-fistula-pcf-100538146","NCT06287034","The Role of the Free\u002FPedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)","Inclusion Criteria:\n\n* Histological confirmation of recurrence\u002Fpersistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:\n\n  1. pre (ChT-)RT staging: cT1\u002FT2\u002FT3 N0\u002FN+;\n  2. pre STL staging: rcT1\u002FcT2\u002F Selected cT3 cT4a (extension to thyroid cartilage and\u002For prelaryngeal tissues) N0\u002FN+ (clinically and radiologically).\n* Indication for STL surgery (no pharyngeal mucosal resection);\n* Functional total laryngectomies after radical (chemo-)radiotherapy treatment;\n* Age \\> 18 years;\n* Signature of informed consent and ability to complete in-office questionnaires.\n\nExclusion Criteria:\n\n* STL extended to the pharynx and\u002For total pharyngeal laryngectomies;\n* Extension of the tumor to the pharyngeal mucosa and\u002For massive extra-laryngeal extension;\n* Previous open organ preservation surgery (OPHL).",{"count":196,"type":22},102,"Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)",[199],"Larynx Carcinoma",[201],"pharyngocutaneous fistula",{"date":86,"type":45},{"date":204,"type":45},"2023-03-21",{"date":206,"type":22},"2027-09-21",{"name":51,"class":52},{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":53},"100612792","generation-of-endometrial-carcinoma-organoids-100612792","NCT07258186","Generation of Endometrial Carcinoma Organoids","Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities","organoids endo","Inclusion Criteria:\n\n* Age \\>18 years;\n* Patients with a histological diagnosis of: endometrial cancer, endometrioid histology, any stage of disease (FIGO I-IV), recurrence\u002Fmetastasis from endometrial endometrioid cancer, and candidates for surgery and\u002For hysterectomy;\n* Written informed consent (study participation and data processing) must be obtained in person and\u002For through a legal representative\u002Fguardian\u002Fsupport administrator\u002Fwitness, before any study-specific procedure is performed.\n\nExclusion Criteria:\n\n* Comorbidities not controlled with adequate medical therapy;\n* Endometrial cavity infections (pyometra);\n* Synchronous tumors;\n* Neoadjuvant treatments;\n* Previous radiation treatments to the pelvic region.",{"count":100,"type":22},"A prospective pilot genetic study to evaluate the feasibility of generating organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice. Samples will be collected from collaborating extramural facilities, with the aim of analyzing the impact of transport on tissue viability and the success of organoid culture. This study is for exploratory purposes only, without altering the diagnostic and therapeutic pathways of the participants.",[219],"Endometrial Cancer","2025-11-27",{"date":222,"type":45},"2025-12-02",{"date":224,"type":45},"2025-03-23",{"date":226,"type":22},"2028-09-23",{"name":51,"class":52},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":178,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100612683","vitamin-k-d-chiro-inositol-and--lactalbumin-in-bone-homeostasis-100612683","NCT07256769","Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis","Synergic Role of Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis in Breast Cancer Patients Treated With Aromatase Inhibitors","Synostea","Inclusion Criteria:\n\n* caucasian women aged between 35 and 70;\n* diagnosed with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues not started more than 12 months ago, about to start treatment with oral bone resorption inhibitors (alendronate);\n* vitamin D levels below 30 ng\u002Fml (test carried out no more than 6 months prior to the baseline\u002FT0 visit)\n* patients able to comply with the procedures and\u002For requirements of the study\n* informed consent to participate in the study and data processing, written personally and\u002For through a witness, before any study-specific procedure is carried out\n\nExclusion Criteria:\n\n* uncontrolled diabetes mellitus (HbA1c 8%), severe CRF (eGFR\\\u003C30 ml\u002Fmin);\n* patients with primary or secondary hyperparathyroidism due to CRF;\n* baseline vitamin D levels greater than 30 ng\u002Fml;\n* patients already being treated with anti-resorptive drugs;\n* patients undergoing steroid therapy;\n* patients undergoing treatment with other forms of vitamin D (calcifediol, calcitriol) or who require high doses of calcium (hypoparathyroidism);\n* patients undergoing treatment with drugs that can affect calcium excretion (diuretics);\n* inability to comply with the procedures required by the study.","35 Years","70 Years",{"count":239,"type":22},134,"In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and\u002For tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. In addition, vitamin K promotes gamma-carboxylation of osteocalcin, causing its activation and leading to increased incorporation of hydroxyapatite into the bone, resulting in increased calcium uptake from the blood and other tissues. Studies have reported that a combination of alendronate and vitamin K2 can lead to a decrease in the ratio of uncarboxylated osteocalcin to carboxylated osteocalcin, contributing to an increase in BMD, especially in the femoral neck. α-lactalbumin is able to increase the bioaccessibility of calcium due to its ability to prevent its precipitation at the neutral pH present in the absorptive tracts of the small intestine. Furthermore, α- lactalbumin has a binding site for vitamin D3, and the complexes formed by monomers of this protein and vitamin D have shown good stability in the presence of high vitamin concentrations. Inositol is a carbohydrate structurally similar to glucose which, in its isomeric form D-chiro-inositol, acts on bone remodeling by blocking the activation of osteoclasts through inhibition of the binding of RANK-L to its receptor present on pre-osteoclasts. Our hypothesis is that the use of the combination of vitamin K, α- lactalbumin, and D-chiro-inositol should improve the intestinal absorption of calcium and vitamin D, increasing the percentage of patients able to normalize serum levels of vitamin D and urinary calcium excretion (as a parameter of adequate calcium intake). This aspect, together with the direct effect of these components on bone remodeling, could enhance the anti-resorptive effect of standard therapy with bisphosphonates, improving the quantitative and qualitative parameters of bone. Therefore, we design a prospective randomized pilot study to assess efficacy of the combination of vitamin K, α-lactalbumin, and D-chiro-inositol, comparing patients with standard therapy and patients treated with Synostea®",[242,243],"Osteoporosis Secondary","Breast Cancer Females",[245,246,247,248,249,250,251],"Vitamin K","d-chiro-inositol","α-lactalbumin","calcium","cancer treatment induced bone loss","vitamin d","synostea","2025-11-25",{"date":254,"type":45},"2025-12-01",{"date":256,"type":45},"2025-09-29",{"date":258,"type":22},"2028-03-31",{"name":51,"class":52},2,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":53},"100612076","pilot-study-for-the-generation-of-cervical-cancer-organoids-from-patients-undergoing-diagnostic-biopsy-100612076","NCT07248878","Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy","Cervical organ","Inclusion Criteria:\n\n* female over 18 years of age;\n* suspected diagnosis of cervical cancer for which a biopsy is indicated according to standard clinical practice;\n* Informed consent (study participation and data processing) given in writing personally and\u002For through the legal representative\u002Fguardian\u002Fsupport administrator\u002Fwitness, before any study-specific procedure is performed.\n\nExclusion Criteria:\n\n* previous malignancies;\n* previous systemic treatments;\n* previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.",{"count":269,"type":22},24,"A meta-analysis showed that neoadjuvant chemotherapy followed by radical hysterectomy reduces the risk of mortality by 35% compared to radiotherapy alone, with a 14% increase in five-year survival. Unfortunately, however, approximately 30% of patients undergoing neoadjuvant chemotherapy are referred for adjuvant radiotherapy or chemoradiotherapy due to the presence of high recurrence risk factors after surgery, which results in a bi- or tri-modal treatment with very serious consequences in terms of toxicity. Infact, approximately 20% of patients treated with radiotherapy experience vaginal discomfort up to 3 years after completing treatment, with significant consequences for the women's quality of life. Therefore, on the one hand, it would be appropriate to identify new drugs that synergize with chemotherapy, reducing the need for adjuvant radiation; on the other, it could be useful to identify patients who could truly benefit from neoadjuvant treatment. To do this, it is necessary to have ex vivo biological models capable of simulating the complexity of the tumor environment and that can be used as a tool to investigate tumor response to specific treatments.\n\nIn this context, tumor organoids represent ideal alternative in vitro models, capable of preserving the characteristics of the original tumors, including their architecture and cell types present. They can be used as avatars for the selection of specific anticancer therapies and for the creation of patient biobanks.",[272,273,274,275],"Cervical Cancer Stage IB2","Cervical Cancer Stage IIa","Cervical Cancer Stage IB","Cervical Cancer Stage IIIA","2025-11-18",{"date":252,"type":45},{"date":279,"type":45},"2025-03-26",{"date":281,"type":22},"2028-03-26",{"name":51,"class":52},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":291,"minAge":292,"maxAge":237,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":53},"100592404","urinary-microbiome-differences-in-bladder-cancer-benign-urinary-diseases-and-healthy-counterparts-in-adult-male-population-100592404","NCT06992986","Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population","Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study","Inclusion Criteria (Bladder Cancer Patients):\n\n* Diagnosis of bladder cancer\n* Negative urine culture\n* Histological confirmation of urothelial carcinoma\n* Patients undergoing radical cystectomy\n\nExclusion Criteria:\n\n* Presence of other neoplasias\n* History of previous BCG therapy\n* Use of indwelling catheter\n* Active antibiotic treatment with two months prior to participation\n* History of sexual transmitted diseases\n* Presence of chronic intestinal inflammation\n* Previous neoadyuvant therapy\n\nInclusion Criteria Controls No-Pathologic\u002FHealthy):\n\n\\- Controls will be collected from men within the specified age range. Eligible controls may be drawn from the institution's personnel attending the occupational medicine department or in service in the Institute.\n\nExclusion Criteria:\n\n* Diabetes\n* Chronic Kidney Disease\n* Cardiac disease\n* Hepatic disease\n\nInclusion Criteria(Benign Urinary Disease)\n\n-To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy.\n\nExclusion Criteria:\n\n* NA",true,"MALE","50 Years",{"count":294,"type":22},50,"The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease",[297],"Bladder Cancer","2025-05-19",{"date":300,"type":45},"2025-05-28",{"date":302,"type":45},"2024-02-06",{"date":304,"type":22},"2025-07-06",{"name":51,"class":52},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":159,"phases":315,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":53},"100592403","efficacy-of-the-association-of-fractionated-srs-and-subsequent-surgery-in-patients-with-brain-metastases-100592403","NCT06992973","Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases","Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases","Inclusion Criteria:\n\n* patients with single metastatic brain lesions with a diameter of ≥ 3 cm symptomatic \u002F asymptomatic or with symptomatic brain lesions ≥ 2 cm \\\u003C 3 cm that are surgically resectable, without or in the presence of max 3 small synchronous lesions amenable to radiosurgery treatment;\n* no urgent surgical indication for neurological symptoms or worsening intracranial hypertension;\n* age ≥ 18 years;\n* performance status according to the Eastern Cooperative Oncology Group (ECOG) scales ≤ 2;\n* Karnfosky Performance Status ≥ 60;\n* life expectancy greater than 3 months;\n* patients assessed as suitable for surgery (ASA score ≤ 3) and in the absence of contraindications to undergoing brain MRI examination without and with contrast medium;\n* ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* contraindications to radiotherapy treatment;\n* pregnancy;\n* inability to follow the procedures, to fill out the questionnaires;",{"count":314,"type":22},98,[316],"NA","In this study, the possibility of performing a preoperative neoadjuvant radiotherapy dose of 27 Gy fractionated in 3 sessions is explored, to maximize the biological effect of the treatment, in patients affected by solid tumors, in particular lung, breast and melanoma, in which brain metastases have arisen, the incidence of which is constantly increasing in relation to the improvements in oncological therapies and the consequent increase in patient survival. It was demonstrated that postoperative stereotactic radiosurgery with this fractionation was effective in improving local disease control at 1 year compared to single-dose stereotactic radiosurgery (91% vs 77%) and in reducing the risk of radionecrosis for metastatic brain lesions of size.",[319],"Brain Metastases",{"date":300,"type":45},{"date":322,"type":45},"2024-09-26",{"date":324,"type":22},"2029-09-26",{"name":51,"class":52},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":291,"minAge":4,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":53},"100584843","genomics-and-efficacy-of-post-prostatectomy-salvage-radiotherapy-with-extreme-hypofractionation-100584843","NCT06894628","Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation","Inclusion Criteria:\n\n* patients enrolled at IRE under the \"esSBRT\" protocol (meeting the criteria of the same);\n* patients who express written informed consent personally or through their legal representative\u002Fwitness\u002Fcurator\u002Fguardian\u002Fsupport administrator (participation in the ancillary study and data processing)\n\nExclusion Criteria:\n\n* all exclusion criteria adopted for the \"esSBRT\" study.",{"count":333,"type":22},103,"The study aims to validate the Decipher® genomic test, in which patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ Gy\u002Ffraction).\n\nValidating the Decipher® genomic classifier based on the expression of 22 RNA genes in the prospective study \"esSBRT\"",[336],"Prostatic Neoplasms","2025-03-18",{"date":339,"type":45},"2025-03-25",{"date":341,"type":45},"2024-11-04",{"date":343,"type":22},"2027-11-04",{"name":51,"class":52},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":53},"100583966","application-of-patient-blood-management-in-the-oncology-patient-affected-by-breast-cancer-100583966","NCT06883201","Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer","Inclusion Criteria:\n\n* age \\> 18 years;\n* patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy;\n* patients who are candidates for destructive and reconstructive breast surgery or not;\n* Hb values less than or equal to 11 g\u002FdL and\u002For transferrin saturation less than or equal to 20%;\n* written informed consent.\n\nExclusion Criteria:\n\n* patients with known allergies to ferric carboxymaltose or its excipients;\n* ferritin values greater than 500 ng\u002Fml;\n* patients unable to sign consent and comply with procedures.",{"count":352,"type":22},78,"Evaluation of the percentage of transfusions in patients with breast cancer undergoing surgery after preventive treatment with haematinics.",[183],"2025-03-12",{"date":357,"type":45},"2025-03-19",{"date":359,"type":45},"2023-01-31",{"date":361,"type":22},"2025-06-30",{"name":51,"class":52},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":290,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":53},"100583368","breast-cancer-and-resilience-in-couple-100583368","NCT06875414","Breast Cancer and Resilience in Couple","Breast Cancer, Resilience, Quality of Life and Depression in Couples From Diagnosis to 24 Months Later: Prospective Pilot Study","resilience","INCLUSION CRITERIA:\n\n* Woman diagnosed with stage 1, 2 or 3 breast cancer\n* age\\> 18 years (patient and partner)\n* The partner must have lived with the woman for at least 6 months at diagnosis and treatment\n* Patients under treatment at the radiotherapy clinic\n* Subjects available and able to answer questionnaires, interviews, and \u002F or participate in focus groups\n* Informed consent\n\nEXCLUSION CRITERIA:\n\nCognitive deficits and \u002F or inability to comply with the provisions of the study",{"count":138,"type":22},"This is a prospective pilot study examining the couple's dyadic attitudes from diagnosis to 24 months later when one member is affected by illness and the adaptive strategies the couple employs when stressful events occur.",[374,375],"Breast Neoplasms","Quality of Life",[377,378,369,379],"breast cancer","quality of life","depression",{"date":381,"type":45},"2025-03-13",{"date":383,"type":45},"2022-11-14",{"date":385,"type":22},"2025-11-14",{"name":51,"class":52},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":290,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":53},"100583569","analysis-of-urinary-methylation-patterns-via-liquid-biopsy-as-an-early-diagnosis-tool-100583569","NCT06878027","Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool","Analysis of Urinary Methylation Patterns Via Liquid Biopsy as a Tool for Early Diagnosis, Non-invasive Monitoring and Prediction of Recurrence Risk in Bladder Cancer","Inclusion Criteria:\n\nPatient group\n\n* age ≥ 18 years\n* proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle)\n* performance status (PS) 0-1\n* ability to follow the procedures established by the study\n* written consent for participation in the study and data processing\n\ngroup of healthy subjects\n\n* age ≥ 18 years\n* ability to follow the procedures established by the study\n* written consent for participation in the study and data processing\n\nExclusion Criteria:\n\nPatient group\n\n* presence of metastatic bladder cancer\n* lack of autonomy in following the procedures established by the study\n\ngroup of healthy subjects\n\n* previous or current clinical history associated with bladder cancer\n* diagnostic suspicion associated with tumor pathologies\n* ongoing or previous systemic oncological treatments\n* presence of inflammatory and\u002For autoimmune diseases related to particular conditions potentially modifying the methylation profile\n* existing pharmacological treatments (and\u002For any other type of treatment) that could alter the results of the analyzes conducted for the present study\n* lack of autonomy in following the procedures established by the study",{"count":395,"type":22},100,"Multicenter, observational, prospective, biological pilot study on liquid biopsy, aimed at investigating methylation profiles in relation to the early diagnosis of bladder cancer, to validate the potential of commercially available tests (e.g. BladderCARE, Bladder EpiCheck), to apply and validate tests based on targeted multi-marker or genome wide analyzes via NGS and to identify methylation profiles as a tool to infer clinical outcome.",[297],[399],"methylation levels in urine samples","2025-03-10",{"date":402,"type":45},"2025-03-14",{"date":404,"type":45},"2024-08-06",{"date":406,"type":22},"2026-02-06",{"name":51,"class":52},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":178,"minAge":19,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":53},"100580772","ai-and-machine-learning-based-risk-prediction-model-to-improve-the-clinical-management-of-endometrial-cancer-100580772","NCT06841653","A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer.","A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer: a Composite Approach Integrating the MultiOMics IMmune-IConographic Pattern (MOMIMIC Score) Towards Precision Oncology and Surgery.","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Histological diagnosis of endometrial hyperplasia, endometrioid adenocarcinoma of the endometrium, healthy endometrium in patients undergoing total hysterectomy for benign extra-endometrial disease;\n* Written informed consent (to the study and data processing), for the party's patients only prospective and\u002For in follow-up) For the retrospective cohort: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 2 years)\n\nExclusion Criteria:\n\nAll exclusion criteria adopted in the surgical protocols will be applied to the study. In particular:\n\n* Comorbidities not controlled with adequate medical therapy;\n* Infections of the endometrial cavity (pyometra);\n* Synchronous cancer;\n* Neoadjuvant treatments;\n* Previous radiotherapy treatments of the pelvic region;\n* Hormone therapies.",{"count":138,"type":22},"Prediction of preoperative endometrial biopsy: the evolution from hyperplasia to cancer, the prognosis and the risk of recurrence. Intelligence methods artificial risk will be used to redefine the current risk classes including our profile immuno-mutational to provide a more precise characterization and closer to the real prognosis of the patient.",[418],"Endometrium Cancer",[420],"MultiOMics IMmune-IConographic pattern","2025-02-18",{"date":423,"type":45},"2025-02-24",{"date":425,"type":45},"2024-06-20",{"date":427,"type":22},"2026-06-20",{"name":51,"class":52},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":53},"100578131","transcriptional-framework-for-the-molecular-diagnosis-of-response-to-immunotherapy-in-lung-cancer-with-agnostic-potential-100578131","NCT06807307","Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential","KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential","KEAPnes","Inclusion Criteria cohort (NSCLC-IC):\n\n* Age \\>18 years;\n* Histological diagnosis of NSCLC\n* metastatic disease\n* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and\u002For radiotherapy);\n* ECOG PS 0-2;\n* Adequate hematological, hepatic and renal function;\n* Measurable disease according to RECIST criteria\n* Availability of follow-up data for at least 6 months and\u002For until death\u002Fprogression\n\nExclusion Criteria cohort (NSCLC-IC):\n\n* Previous systemic therapy for metastatic disease;\n* Comorbidities not controlled with adequate medical therapy.\n\nInclusion Criteria NSCLC-VC cohort:\n\n* Age \\>18 years;\n* Histological diagnosis of NSCLC\n* metastatic disease\n* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and\u002For by biopsy) before administration of any anti-tumor treatment (chemotherapy and\u002For radiotherapy);\n* ECOG PS 0-2;\n* Adequate hematological, hepatic and renal function;\n* Measurable disease according to RECIST criteria;\n* Written informed consent (participation in the study and data processing)\n\nExclusion Criteria NSCLC-VC cohort:\n\n* Previous systemic treatment for metastatic disease;\n* Comorbidities not controlled with adequate medical therapy;",{"count":438,"type":22},256,"Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.",[32],{"date":442,"type":45},"2025-02-04",{"date":444,"type":45},"2024-06-04",{"date":65,"type":22},{"name":51,"class":52},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":455,"studyType":23,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":53},"100576949","study-of-the-contribution-of-mutant-p53yap-proteins-to-therapy-resistance-in-recurrent-head-and-neck-cancer-100576949","NCT06791941","Study of the Contribution of Mutant p53\u002FYAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer","Inclusion Criteria:\n\n* Age over 18\n* Patients with squamous cell tumors of the oral cavity, pharynx or larynx\n* Surgical patients with primary HNSCC tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.\n* Availability of adequate material (tissue) for the planned analyses\n* Availability of follow-up data for at least one year (retrospective part)\n* Written informed consent (prospective part and\u002For, for the retrospective part, traceable patients and\u002For patients in follow-up and\u002For if necessary for the legal nature\u002Finstitutional purposes of the participating centers).\n\nExclusion Criteria:\n\n* Presence of distant metastases at the time of diagnosis\n* Previous head and neck cancer\n* Second cancer undergoing treatment or follow-up for less than 5 years",{"count":454,"type":22},18,"12 Months","Multicenter, non-interventional, retrospective\u002Fprospective study of a biological nature, on patients affected by head and neck tumors, for which the collection and use of tissue samples is planned for the study of the mutational profile, the transcriptional profile and the proteomic profile.",[458],"Head and Neck Tumors",[460,461,462],"head and neck tumors","TP53","organoids","2025-01-23",{"date":465,"type":45},"2025-01-24",{"date":467,"type":45},"2024-03-07",{"date":469,"type":22},"2029-03-07",{"name":51,"class":52},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":479,"studyType":23,"phases":4,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":53},"100576617","development-of-organoids-from-primary-colorectal-tumors-and-synchronous-liver-metastases-100576617","NCT06787625","Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases","Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases","Inclusion Criteria:\n\n* Patients \\> 18 years\n* Histological and cytological diagnosis of colorectal cancer neoplasia that has developed a liver metastasis\n* Patients who are candidates for surgery for colorectal cancer with liver metastasis\n* Signing of the relevant informed consent form.\n\nExclusion Criteria:\n\n* All exclusion criteria adopted in surgical protocols will be applied to the study",{"count":120,"type":22},"36 Months","Pilot feasibility study for the development of organoids from primary colorectal tumors and synchronous liver metastases, to prepare organoids from primary colorectal tumors and synchronous liver metastases. The organoids will allow us to study the function of genes targeted by the activity of the NF-Y\u002Fp53 complex.",[482],"Colo-rectal Cancer",[484,462],"colororectal cancer","2025-01-16",{"date":487,"type":45},"2025-01-22",{"date":489,"type":45},"2024-05-25",{"date":491,"type":22},"2028-05-25",{"name":51,"class":52},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":4,"enrollmentInfo":500,"targetDuration":479,"studyType":23,"phases":4,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":53},"100576543","male-mamm-organoids-100576543","NCT06786663","MALE Mamm Organoids","Feasibility Study for the Generation of Organoids From Male Breast Tumors","Inclusion Criteria:\n\n* Men aged \\>18 years\n* Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention\n* Adequate biological material to be able to carry out the analyses described above\n* Signing of the relevant informed consent form\n\nExclusion Criteria:\n\nnot present",{"count":501,"type":22},7,"It is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. Furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.",[504],"Breast Neoplasms, Male",[506],"Organoids","2025-01-15",{"date":487,"type":45},{"date":510,"type":45},"2024-04-19",{"date":512,"type":22},"2027-04-19",{"name":51,"class":52},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":159,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":53},"100572649","myo-inositol-and-selenium-in-indeterminate-thyroid-nodules-tir3a-100572649","NCT06736015","Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)","Use of Myo-inositol and Selenium in Patients with Indeterminate Thyroid Nodules (TIR3A)","MYOSEL","Inclusion Criteria:\n\n* Adult (\\>18 years old),\n* both sexes,\n* patients presenting thyroid nodules classified as TIR 3A, based on cytological evaluation on sample from the first fine needle aspiration (FNA),\n* written Informed consent,\n* Patients with appropriate material for subsequent immunocytochemical analysis of Ki-67 and PCNA\n\nExclusion Criteria:\n\n* Patients with diagnosed thyroid malignancies of cytological diagnosis other than TIR3A\n* pathological levels of the thyroid stimulating hormone (TSH) which required L-Thyroxine treatment starting\n* pregnancy and\u002For breastfeeding",{"count":523,"type":22},30,[316],"Thyroid nodules present a variable risk of malignancy depending on the cytological result obtained from the ultrasound-assisted thyroid fine needle aspiration biopsy. According to the Italian Cytology classification SIAPEC-IAP 2014, the TIR3A nodules are indeterminate nodules with a risk of malignancy lower than 10%. Clinical and instrumental follow-up is recommended in these cases, including repetition of the fine needle aspiration.\n\nA study have demonstrate the effect of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of benign thyroid nodules.\n\nOur hypothesis is that the use of this supplement can determine a reduction in the size and consistency of the nodule assessed through ultrasound and elastosonography also in cytologically indeterminate (TIR3A) nodules and that treatment can reduce the cellular proliferation of these nodules assessed by immunocytochemistry.\n\nTherefore, we design a prospective randomized pilot study to assess efficacy and safety of myo-inositol and selenium in TIR3a thyroid nosules, comparing treated and untreated patients.",[527],"Thyroid Nodule",[529,530,531,532],"TIR3A","indeterminate thyroid nodules","myo-inositol","selenium","2024-12-13",{"date":535,"type":45},"2024-12-16",{"date":537,"type":45},"2024-10-23",{"date":539,"type":22},"2026-10-30",{"name":51,"class":52},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":53},"100499931","gender-based-impact-on-safety-and-efficacy-of-lenvatinib-in-patients-with-differentiated-thyroid-cancer-100499931","NCT05789667","Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer","Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer","Gisel","Inclusion Criteria:\n\n* Patients with refractory iodine DTC treated with lenvatinib\n* Signed written informed consent\n\nExclusion Criteria:\n\n\\- Age \\\u003C 18 years",{"count":294,"type":22},"Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer.\n\nThe primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.",[552,553],"Differentiated Thyroid Cancer","Gender","2024-12-05",{"date":556,"type":45},"2024-12-06",{"date":558,"type":45},"2020-05-27",{"date":560,"type":22},"2025-12-31",{"name":51,"class":52},""]