[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centro di Riferimento Oncologico - Aviano\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":548},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,38,61,81,105,129,149,167,191,211,231,251,271,291,310,332,353,374,398,418,437,457,478,498,519],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100634388","effects-of-physical-activity-in-early-stage-hormone-receptor-positive-breast-cancer-patients-100634388",false,"NCT07539038","Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients","Inclusion Criteria:\n\n* Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy\n* Female patients ≥18 years of age\n* Written informed consent must be obtained before any study-related assessment is performed\n* Participation to the Medicina and Sport physical activity program organized by Andos Pordenone\n\nExclusion Criteria:\n\n* Patients with early hormone receptor negative breast cancer\n* Patients with early hormone receptor positive breast cancer receiving chemotherapy\n* Patients with advanced\u002Fmetastatic breast cancer.\n* Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias).\n* Patients with history of vertebral and\u002For femoral fractures\n* Patients with CVDs not optimally controlled by medical therapy","FEMALE","18 Years",{"count":19,"type":20},44,"ESTIMATED","OBSERVATIONAL","The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.\n\nThis is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).",[24],"Breast Cancer","RECRUITING","2026-04-13",{"date":28,"type":29},"2026-04-20","ACTUAL",{"date":31,"type":29},"2025-04-03",{"date":33,"type":20},"2027-12-31",{"name":35,"class":36},"Centro di Riferimento Oncologico - Aviano","OTHER",1,{"id":39,"slug":40,"hasResults":12,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":12,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":37},"100633494","textual-analysis-of-narratives-produced-by-adolescent-oncology-patients-a-research-project-100633494","NCT07527416","Textual Analysis of Narratives Produced by Adolescent Oncology Patients: A Research Project","Testi AYA","Inclusion Criteria:\n\n* adolescents and young adults treated at the Area giovani CRO from 2021\n* willing to participate at the study\n\nExclusion Criteria:\n\n* absence of informed consent","ALL","13 Years","25 Years",{"count":49,"type":20},500,"This research project builds on a long-standing tradition within our Institute of documenting \"free thoughts\" and personal reflections shared by adolescent oncology patients and their families. These narratives, collected through \"logbooks\" in ward rooms and during dedicated events-including those focused on the COVID-19 pandemic-represent a profound tool for patients to reclaim their identity beyond their diagnosis.\n\nThe aim is to stimulate and collect patient narratives to better understand their emotional and lived experiences. By analyzing these spontaneous writings, the study aims to improve clinical practice, enhance the patient-provider relationship, and optimize the overall healthcare organization.",[52],"Cancer","2026-04-07",{"date":55,"type":29},"2026-04-14",{"date":57,"type":29},"2021-09-01",{"date":59,"type":20},"2027-12",{"name":35,"class":36},{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":37},"100632728","the-assessment-of-preoperative-anxiety-in-cancer-patients-validation-observational-descriptive-study-100632728","NCT07517458","The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.","V-ANXIETY","Inclusion Criteria:\n\n* In ordinary hospitalization, day surgery, day hospital\n* Age ≥ 18 years\n* Signature of consent participation in the study and personal data collection and processing\n* Good understanding of the Italian language\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient\n* Difficulty in understanding the Italian language",{"count":69,"type":20},180,"The study stems from the need to have available effective tools for detecting the anxiety of the cancer patient who has to undergo surgery.\n\nThe period leading up to surgery, is characterized by strong emotions that create an upheaval in the work, family and social life of the patient as well as concern about the unknown.\n\nIt would be crucial to ensure a personalized nursing care by having scales of assessment specific to the clinical-surgical oncology setting in order to collect the patient's emotions, concerns and fears.\n\nDespite the numerous scales available, many of them have limitations concerning the issues they go to investigate but also concerning the timeframes for compilation, which are often long and laborious so they are difficult to apply.\n\nThe study aims to validate in the Italian context the Surgical Anxiety Questionnaire (SAQ) questionnaire, already translated and validated in multiple languages, to detect which factors are the most influential in increasing preoperative anxiety, with the aim of implementing education of the patient and implement strategies and interventions that can reduce anxiety.",[72],"Anxiety","2026-04-01",{"date":75,"type":29},"2026-04-08",{"date":77,"type":29},"2024-05-23",{"date":79,"type":20},"2026-12-01",{"name":35,"class":36},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":45,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100626295","reference-intervals-with-indirect-methods-in-italy-100626295","NCT07433777","Reference Intervals With Indirect Methods in Italy","REFIND-IT","Inclusion Criteria:\n\n* no one\n\nExclusion Criteria:\n\n* no one",true,"0 Years","100 Years",{"count":92,"type":20},1000000,"Reference intervals are an essential tool for the clinical interpretation of laboratory test results. Traditionally, these interval are determined using samples from healthy individuals, a process that is resource-intensive, time-consuming, and require the active recruitment of healthy volunteers.\n\nIn recent years, due to the increasing availability of electronic health record (EHR) databases and the growing number of laboratory tests, it is possible to determine the reference intervals indirectly. This approach relies on the analysis of routine data acquired in clinical laboratories, eliminating the need for active recruiting healthy subjects and significantly reducing costs. Moreover, the method has the potential to eliminate the selection bias of an ultra-healthy population typical of the direct methods. The indirect methods for determining reference intervals have evolved from simple strategies of isolating the healthy population using sample metadata, to sophisticated statistical models that effectively distinguish normal from pathological distributions. One of the advanced techniques, RefineR, has reached an excellent combination of accuracy, robustness, and computational efficiency, outperforming previous methods. It has been implemented as an open-source R package, facilitating its application in real-world settings.\n\nIn recognition of these advantages, the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), through its Committee on Reference Intervals and Decision Limits (C-RIDL), has promoted the adoption of indirect methods for determining reference intervals, highlighting the advantages of this strategy, including greater speed, lower costs, and the absence of a need to recruit healthy donors.\n\nFurthermore, a recent study has highlighted age-related physiological variations in hemoglobin levels in elderly population. This underscores the need for defining age-specific reference intervals which are currently absent from most laboratory reports, potentially impacting diagnostic accuracy.",[95],"Reference Intervals","2026-02-19",{"date":98,"type":29},"2026-02-25",{"date":100,"type":29},"2025-10-08",{"date":102,"type":20},"2028-06-01",{"name":35,"class":36},24,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":16,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100623514","endoscopic-suture-gastroplasty-esg-for-treatment-of-obese-patients-with-endometrial-cancer-100623514","NCT07397624","Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer","Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer: a Prospective, Multicenter, Observational Study (ESG-ENDO)","ESG-ENDO","Inclusion Criteria:\n\n* Women with endometrial cancer scheduled for hysterectomy with a curative intent\n* Age 21-75\n* BMI ≥ 30\n* Willingness to undergo E-ESG and lifestyle modifications program\n* Willingness to comply with the substantial lifelong dietary restrictions required by the procedure\n* Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling\n* Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)\n* Prior gastrointestinal surgery with sequelae, i.e., obstruction, and\u002For adhesive peritonitis or known abdominal adhesions\n* Prior open or laparoscopic bariatric surgery\n* Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery\n* Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n* Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenoses\n* Gastrointestinal stromal tumors, history of premalignant gastric lesions (advanced atrophic gastritis), history of familial and non-familial adenomatous syndromes\n* A gastric mass or gastric polyps \\> 1 cm in size\n* A hiatal hernia \\> 4 cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms\n* A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope\n* Achalasia or any other severe esophageal motility disorder\n* Severe coagulopathy\n* Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy\n* Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis, or intractable constipation\n* Hepatic insufficiency or cirrhosis\n* Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing\n* Active psychological issues preventing participation in a life-style modification program as determined by a psychologist\n* Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up\n* Patients who are unable or unwilling to take prescribed proton pump inhibitor medication\n* Patients receiving daily prescribed treatment with high dose aspirin (\\> 80 mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants\n* Patients who are pregnant or breast-feeding\n* Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs\n* Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications\n* Subjects who are taking corticosteroids, immunosuppressants, and narcotics\n* Subjects who are taking diet pills\n* Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease\n* Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n* Diagnosis of autoimmune connective tissue disorder (e.g., lupus, erythematosus, scleroderma) or immunocompromised\n* Specific diagnosed genetic disorder such as Prader Willi syndrome\n* Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating\n* Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism","21 Years","75 Years",{"count":116,"type":20},74,"Obesity increases the risk of endometrial cancer, with higher Body Mass Index (BMI) leading to a significant increase in both cancer risk and recurrence. Because of the excellent cancer-specific outcomes and preponderance of obesity-related complications, women with endometrial cancer are more likely to die of cardiovascular disease and other obesity-related illnesses than endometrial cancer itself. This makes an endometrial cancer diagnosis a critical moment to emphasizes the importance of actively managing the underlying issue of obesity in the endometrial cancer survivorship period.\n\nBariatric surgery has shown long-term benefits, including weight loss and reduction of obesity-related comorbidities, and has been linked to a decrease in endometrial cancer incidence. However, bariatric surgery has limitations, such as irreversibility and potential complications. Recent interest in less invasive methods, like bariatric endoscopy, shows promising results in achieving weight loss and improving metabolic profiles. Endoscopic procedures, such as Endomina Endoscopic suture gastroplasty (E-ESG), have shown effectiveness in weight loss and could offer a safer, more accessible alternative to surgery, in particular if associated to a lifestyle modifications program. Efficacy and safety of Bariatric endoscopy has been stressed within the recently published \"Guideline of the Italian Society of Surgery of Obesity and Metabolic Diseases on Bariatric Endoscopy in the treatment of obesity and associated complications\" that suggest the use of bariatric endoscopy in patients with class I obesity and in patients with class II obesity regardless of the presence of comorbidities, for the treatment of obesity.\n\nThis study aims to assess the feasibility and safety of the E-ESG procedure in treating obesity in women after curative treatment for endometrial cancer.",[119],"Endometrial Cancer","2026-02-10",{"date":122,"type":29},"2026-02-12",{"date":124,"type":29},"2026-01-08",{"date":126,"type":20},"2029-12-31",{"name":35,"class":36},2,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":90,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":37},"100621754","identification-of-biomarkers-of-risk-for-pre-neoplastic-and-neoplastic-lesions-for-the-development-of-gastric-cancer-100621754","NCT07374731","Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer","DSCb score","Inclusion Criteria:\n\n* Aged over 18;\n* Ability to understand, accept, and sign the informed consent form for the study;\n* Ability to understand, accept, and sign the consent form for data processing;\n* Ability to understand, accept, and sign the consent form for the collection of a serum sample for research purposes;\n* Patients who are fasting and have requested a pepsinogen test or gastroscopy, or who have gastric cancer prior to treatment;\n* Subjects who are fasting and have suspected pre-neoplastic\u002Fneoplastic gastric lesions or who have requested a pepsinogen test and for whom endoscopic examination data are available.\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Pregnant women\n* Patients with a coexisting or previous diagnosis of another malignant neoplasm in the last 5 years\n* Patients unable to understand, accept, and sign the consent form for data processing",{"count":137,"type":20},192,"Investigator propose the implementation of circulating biomarker monitoring, focusing on molecules related to the progression of gastric atrophy and\u002For associated with gastric cancer.\n\nMonitoring these biomarkers will provide gastroenterologists with timely information on individuals at risk and, if values worsen during follow-up, will alert physicians observing these patients to evaluate them.\n\nThis monitoring will be offered to individuals who contact the IBO (Immunopatologia e Biomarcatori Oncologici) Unit at CRO (Centro di Riferimento Oncologico) in Aviano requesting an assessment of gastric function through pepsinogen and G17 gastrin level testing. Monitoring these biomarkers will provide a dynamic analysis of patients' gastric status, allowing for timely intervention in case of deviations from normal values. This proactive approach is important for the preventive management of gastric diseases, particularly for the diagnosis and monitoring of gastric atrophy and gastric cancer.\n\nThe IBO unit of the CRO in Aviano, together with the pathological anatomy and clinical units of gastroenterology, medical oncology, and surgery, will play a role in coordinating and implementing this monitoring program, thus contributing to the promotion of gastric health and the prevention of associated diseases.",[140],"Gastric Cancer","2026-01-29",{"date":143,"type":29},"2026-02-02",{"date":145,"type":29},"2025-05-21",{"date":147,"type":20},"2027-01-31",{"name":35,"class":36},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":37},"100619418","prostate-cancer-research-using-cross-validation-of-innovative-sampling-integrating-lc-msms-for-optimized-therapeutic-drug-monitoring-100619418","NCT07344363","Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS\u002FMS for Optimized Therapeutic Drug moNitoring","PRECISION","Inclusion Criteria:\n\n* Patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide according to the dosing regimens described in the Summary of Product Characteristics. The treatment cycle does not matter but patients should be at the steady state (see section 4.2);• Age ≥18;\n* Signed informed consent is required\n\nExclusion Criteria:\n\n* Conditions that may limit the ability to adequately comply with the study procedures outlined in the protocol;\n* Refusal of informed consent;\n* Any condition that, in the investigator's judgment, could compromise appropriate participation in the study.",{"count":157,"type":20},100,"Applying Dried Blood Spots (DBS) techniques to pharmacokinetic analysis could significantly streamline the use of Therapeutic Drug Monitoring (TDM) in clinical practice. To establish DBS as a viable alternative sampling method, it is essential to demonstrate that results obtained from DBS analysis are reliable. This validation can be achieved through a cross-validation study. In this protocol, an original validated method, the plasma-based assay, serves as the \"reference\", while the alternative DBS-based analytical technique is the \"comparator.\" The reliability will be defined analysing patients' samples with the new methods and comparing these results with those obtained with the reference LC-MS\u002FMS (Liquid Chromatography-Mass Spectrometry) methods (in plasma). The possibility to apply DBS technique to pharmacokinetic analysis should largely facilitate the application of TDM to clinical practice.",[160],"Prostate Cancer",{"date":143,"type":29},{"date":163,"type":29},"2025-11-19",{"date":165,"type":20},"2027-11-19",{"name":35,"class":36},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":45,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":37},"100579904","somatostatin-receptor-pet-imaging-to-guide-radiotherapy-dose-escalation-in-high-risk-meningiomas-100579904","NCT06830356","Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.","SPIDER-MEN","Inclusion Criteria:\n\n* Age ≥ 16 years;\n* Ability to express appropriate informed consent to treatment;\n* Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;\n* In case of recurrence, confirmation can be either histological or radiological;\n* Not previous brain-level radiotherapy;\n* Performance status: ECOG=0-2.\n\nExclusion Criteria:\n\n* Refusal to radiation treatment (i.e., absence of signed informed consent);\n* Other concomitant oncologic therapies\n* Current pregnancy;\n* Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;\n* Inability to perform MRI with MoC or PET.","16 Years",{"count":176,"type":20},53,"INTERVENTIONAL",[179],"NA","High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.",[182],"Meningioma","2025-02-11",{"date":185,"type":29},"2025-02-17",{"date":187,"type":29},"2024-12-23",{"date":189,"type":20},"2037-12-23",{"name":35,"class":36},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100572837","precision-retrospective-integrative-study-for-metastatic-lymph-nodes-in-breast-cancer-100572837","NCT06738459","Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer","PRISM","Inclusion Criteria:\n\n* Patients diagnosed with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment\n* Patients of all genders, ages, and stage I-III of breast cancer\n* Patients who underwent neoadjuvant therapy and have longitudinal imaging data available for analysis (for secondary outcome analysis)\n\nExclusion Criteria:\n\n* Patients whose MRI images were of insufficient quality for analysis\n* Patients who had a previous history of breast cancer\n* Patients with a history of axillary surgery or lymph node dissection prior to the current diagnosis of breast cancer\n* Patients who received neoadjuvant therapy at another institution",{"count":199,"type":20},1500,"Accurate assessment of axillary lymph nodes in patients with breast cancer is essential for prognosis and treatment planning. Staging and surgical management have evolved from axillary lymph node dissection to sentinel lymph node biopsy to minimize morbidity. However, sentinel lymph node biopsy has non-negligible morbidity, and more than 70% of biopsies are negative, calling into question its routine use. Magnetic resonance imaging (MRI) can be used to detect and stage lymph node metastases in situ, but its sensitivity and specificity are moderate to poor. Few studies have employed artificial intelligence to detect lymph node metastases on MRI images, and none have used an integrative multidata approach (IMA), defined as modeling the combination of clinical and laboratory data with multiparametric MRI.\n\nThe primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement",[24],"2024-12-12",{"date":204,"type":29},"2024-12-17",{"date":206,"type":20},"2025-01-01",{"date":208,"type":20},"2026-07-31",{"name":35,"class":36},4,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":210},"100571305","characterization-of-immune-genotypes-and-antibody-profiles-to-foster-the-discovery-of-diagnosticbiomarkers-of-liver-cancer-development-100571305","NCT06718530","Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development","VERYMARKERS","Inclusion Criteria:\n\n* Patients aged ≥18 years with the presence of chronic infection, fibrosis, cirrhosis or HCV- associated HCC\n* Patients able to understand and willing to sign the of informed consent\n* Patients to answer the questions in the questionnaire of enrollment\n\nExclusion Criteria:\n\n* Treatment for other oncological diseases\n* Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)",{"count":219,"type":20},1000,"Hepatitis C virus (HCV), which infects more than 185 million people, is a major risk factor. Direct-acting antiviral (DAA) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of HCC, so careful surveillance is necessary. The genetic diversity of the natural killer receptor, histocompatibility antigens (HLA) and interferon lambda 4 (INFL4) activity, among other factors, have been found to be crucial in directing disease progression. Importantly, these markers are detectable years before the diagnosis of HCC. In addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as IFNL4 and HLA-E, have been shown to be predictive for the development of HCC and have not yet been extensively studied. The aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific HCV proteome peptides, IFNL4 expression, and the interaction of specific HLA receptors\u002Fligands in a large cohort of HCV-positive subjects in order to create a screening strategy for the early diagnosis of HCV-associated HCC.\n\nPart of the study will be devoted to describing the immune microenvironment associated with the expression of IFNL4 and HLAE, evaluating them as potential prognostic indicators for HCC in HCV-infected subjects undergoing surgery for HCC, as well as in those with advanced\u002Fmetastatic HCC.",[222],"Hepatitis C Virus Infection","2024-12-02",{"date":225,"type":29},"2024-12-05",{"date":227,"type":29},"2024-05-13",{"date":229,"type":20},"2026-12-31",{"name":35,"class":36},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":88,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":37},"100567486","clinical-nursing-practice-supported-by-results-of-research-mixed-method-study-100567486","NCT06668818","Clinical Nursing Practice Supported by Results of Research: Mixed-method Study","PRACTICE","Inclusion criteria for nurses:\n\n* All nurses employed at IRCCS-CRO Aviano under fixed-term and permanent contract on 15 September 2023;\n* Nursing activities in the departments of medical and surgical oncology and high technologies;\n* Full-time and part-time employment contract;\n* Signature of consent for participation in the study and processing of personal data (Privacy).\n\nPatient inclusion criteria:\n\n* Patients admitted to the institution as in-patients;\n* Age ≥ 18 years;\n* Signature of consent for participation in the study and processing of personal data (Privacy);\n* Good understanding of the Italian language.\n\nExclusion criteria for nurses:\n\n\\- Lack of willingness\u002Finterest in participating in the study and signing the consent.\n\nPatient exclusion criteria:\n\n* Day-Hospital patients;\n* Age \\\u003C 18 years;\n* Diagnosis of cognitive dysfunction or psychiatric disorders;\n* Difficulties in understanding the Italian language.",{"count":239,"type":20},205,"The purpose of the study is to assess the attitudes and the use of research by nurses at the IRCCS-CRO Aviano. Furthermore, it will make it possible to identify attitudes towards the use\u002Fnon-use of research results, specific training needs and targeted interventions to ensure adequate care for cancer patients along the disease course, derived from a constant updating of nursing skills. The study will involve nurses working in different care settings of the Institute and some patients who will be able to express their care needs and research priorities, making a direct contribution towards development of care centred on the health needs, preferences and values of the cancer patients.",[242],"Oncology","2024-11-29",{"date":245,"type":29},"2024-12-03",{"date":247,"type":29},"2024-03-07",{"date":249,"type":20},"2025-03-07",{"name":35,"class":36},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":177,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":128},"100565207","effectiveness-of-an-n-acetylcysteine-and-urea-based-cream-in-prevention-of-capecitabine-induced-hand-foot-syndrome-in-breast-cancer-patients-100565207","NCT06639178","Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients","Phase II Trial to Determine the Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients","HAND-TO-HAND","Inclusion Criteria:\n\n* Women and men ≥18 years old\n* Patients with diagnosis of breast cancer with stage I-III radically operated with residual disease post neoadjuvant treatment or stage IV\n* Patients candidated for capecitabine in a post-neoadjuvant or metastatic setting treated with 2000-2500 mg\u002Fm2 d1-14 q21, or 1500 mg daily continuously (metronomic schedule)\n* Patients who provided written informed consent\n\nExclusion Criteria:\n\n* Patients previously treated with drugs that may have induced HFS\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatmen",{"count":7,"type":20},[179],"Breast cancer (BC) is the most frequent tumour in women. To date, among the available treatments, the use of Capecitabine, an oral prodrug of fluorouracil, has been shown activity in different setting. In advanced disease, Capecitabine is often used as monotherapy in patients pretreated with anthracycline, taxane or both.\n\nOne of the most frequent toxicities reported by patients receiving capecitabine is hand-foot syndrome (HFS), with an incidence of grade 3 HFS of 28%. HFS, also known as palmar-plantar erythrodysesthesia syndrome, is initially characterized by palmoplantar numbness, tingling, or burning pain. These symptoms usually coincide with sharply demarcated erythema with or without edema, cracking, or desquamation. In advanced stages, blistering and ulceration may occur. Although HFS is not considered life threatening, it can be painful and interfere with daily activities, thusseriously compromising quality of life (QoL), therefore this toxicity is considered dose limiting.Moreover, consistent with the theory that Capecitabine and its metabolites induce an inflammatory effect, the use of COX-2 inhibitors is an emerging strategies, but more evidence are needed from largest study to confirm their efficacy.\n\nSimilarly, N-acetylcysteine (NAC), an antioxidant, mucolytic and nephroprotective agent, that affects pathways involved in inflammatory conditions and that has demonstrated to be effective in several dermatologic conditions, could be useful in the management of Capecitabine-induced HFS.\n\nFrom this arises the present study that has the objective of evaluating the role of NAC plus urea-based cream in the prevention of Capecitabineinduced HFS in patient affected by breast cancer.",[24],"2024-10-14",{"date":265,"type":29},"2024-10-16",{"date":267,"type":29},"2024-08-01",{"date":269,"type":20},"2026-05-15",{"name":35,"class":36},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":45,"minAge":4,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":37},"100565206","retrospective-perspective-observational-cohort-study-on-toxicity-and-efficacy-of-radiotherapy-in-pediatric-and-adult-patients-with-pediatric-histology-treated-at-the-pediatric-radiotherapy-of-the-cro-in-aviano-100565206","NCT06639165","Retrospective-perspective Observational Cohort Study on Toxicity and Efficacy of Radiotherapy in Pediatric and Adult Patients With Pediatric Histology Treated at the Pediatric Radiotherapy of the CRO in Aviano","RADIOPED","Inclusion Criteria:\n\n* Pediatric, adolescent, and young adult (\\\u003C25 years old) patients with malignant neoplasm\n* Adult patients (≥25 years) with malignant neoplasm with histology typical of pediatric age but rarely also found in adults and typically treated wherever possible in pediatric protocols (mainly: Central nervous system malignancies such as medulloblastomas and other embryonal tumors, ependymomas, and germ cell tumors; soft tissue and bone sarcomas such as rhabdomyosarcomas and Ewing's sarcomas; nephroblastomas; neuroblastomas)\n* Underwent radiation treatment at the Pediatric Radiotherapy Unit of the CRO in Aviano\n* Between October 24, 1991, and September 30, 2020, with regard to the retrospective phase of the study, and between October 1, 2020, and September 30, 2030, with regard to the prospective phase of the study\n* And who provide informed consent to the study if alive and traceable at the time of enrollment with regard to the retrospective phase of the study and necessarily with regard to the prospective phase. Regarding deceased or alive but untraceable patients enrollable in the retrospective phase of the study, since these are patients who had already given consent to data processing at the time of the radiation therapy being analyzed and registration\u002Fenrollment in any specific treatment\u002Fresearch protocols, no new consent is required for the study\n\nExclusion Criteria:\n\n\\- Anything not covered in the inclusion criteria",{"count":279,"type":20},280,"Radiotherapy key role in pediatric oncology, despite the potential side effects especially in the long term, including the risk of radioinduced second cancers.\n\nVery rarely malignant neoplasms typical of children and adolescents may present in adulthood, historically with a worse outcome, but for some of these histologies demonstrated recent results overlapping with those in pediatric age when treated with strategies similar to pediatric protocols and similar radiotherapy.\n\nLong-term data on outcome and incidence of potential toxicity late radiation therapy in these populations almost exclusively from epidemiologic studies or retrospective case series. Prospective data are lacking, particularly in patients treated with IMRT and specifically with certain IMRT modalities such as Helical Tomotherapy, for which the CRO pediatric radiotherapy has documented experience. The main objective is to evaluate the short- and long-term toxicity secondary to radiotherapy performed at the Pediatric Radiotherapy of the CRO in Aviano, with specific subgroup analyses aimed at highlighting any differences mainly by age, pathology and radiotherapy technique.",[282],"Radiation Toxicity","2024-10-10",{"date":285,"type":29},"2024-10-15",{"date":287,"type":29},"2020-10-01",{"date":289,"type":20},"2030-09-30",{"name":35,"class":36},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":37},"100565066","identification-of-prognostic-and-predictive-biomarkers-of-toxicity-in-patients-with-malignant-pleural-mesothelioma-and-treated-with-high-doses-of-radiotherapy-mesortibo-100565066","NCT06637345","Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)","MESORTIBO","Inclusion Criteria:\n\n* Over 18 years of age;\n* Ability to understand, accept and sign consent informed;\n* Histological diagnosis of malignant pleural mesothelioma;\n* Previous administration of chemotherapy;\n* Previous non-radical surgical approach (diagnostic thoracoscopy or R1-R2 surgery);\n* Subject eligible for or already treated with RT on hemithorax for radical purposes (50 Gy in fractions on hemithorax + possible boost 60 Gy on residual PET+)\n\nExclusion Criteria:\n\n* Disease not histologically established\n* Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);\n* Metastatic patient at diagnosis.",{"count":299,"type":20},52,"Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.\n\nIn other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.\n\nBoth treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.\n\nThis study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and\u002For markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.",[302],"Pleural Mesothelioma Malignant","2024-10-09",{"date":285,"type":29},{"date":306,"type":29},"2024-03-15",{"date":308,"type":20},"2027-03-15",{"name":35,"class":36},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100563737","development-of-an-artificial-intelligence-model-for-optimising-therapy-in-gliomas-gliomas-100563737","NCT06620055","Development of an Artificial Intelligence Model for Optimising Therapy in Gliomas Gliomas","Development of an Artificial Intelligence Model for Optimising Therapy in Gliomas","GLIO-AI","Inclusion Criteria:\n\n1. Patients with a histopathological diagnosis of glioma for whom it is possible to have cryopreserved or fixed in formalin and embedded in paraffin biological material. Specimens may result from incisional biopsy and\u002For surgical resection and\u002For blood. Whole blood is taken for germinal analysis;\n2. Age \\>=18 years;\n3. Patients must understand and provide written informed consent;\n4. Life expectancy \\>3 months;\n5. Presence of biological material from resection and blood considered sufficient by quality and quantity to proceed to molecular characterisation in the opinion of the Investigator Principal Investigator;\n6. Presence of available and accessible clinical and histopathological data.\n\nExclusion Criteria:\n\n1. Refusal of informed consent;\n2. Uncooperative patients;\n3. Presence of other neoplastic diseases in the last 5 years;\n4. Pregnant and\u002For breastfeeding women",{"count":319,"type":20},164,"Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods.\n\nWith this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose.",[322],"Glioma","2024-09-26",{"date":325,"type":29},"2024-10-01",{"date":327,"type":29},"2023-11-16",{"date":329,"type":20},"2028-11-16",{"name":35,"class":36},3,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":344,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":37},"100563492","study-of-the-predictive-and-prognostic-role-of-pharmacogenetic-and-radiogenic-variants-on-the-response-to-neoadjuvant-chemoradiation-therapy-in-patients-with-locally-advanced-rectal-cancer-100563492","NCT06616870","Study of the Predictive and Prognostic Role of Pharmacogenetic and Radiogenic Variants on the Response to Neoadjuvant Chemoradiation Therapy in Patients With Locally Advanced Rectal Cancer","IGLarc","Eligibility criteria:\n\n1. histologically confirmed diagnosis of primary resectable LARC;\n2. confirmed absence of distant metastases;\n3. ≥18 years old;\n4. stage of disease T3-T4 and N0-N2;\n5. performance status (World Health Organisation) 0-2;\n6. normal bone marrow, kidney and liver function;\n\nExclusion Criteria:\n\n1. evidence of secondary tumour\n2. inadequate liver function (bilirubin \\>1.5 times the normal range, ALT and AST \\>2 times the normal range);\n3. inadequate renal function (creatinine \\>1.5 times the upper limit of normal range);\n4. Major concomitant systemic diseases that contraindicate surgery;\n5. significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension)\n6. systemic disease contraindicating radiotherapy",{"count":340,"type":20},460,"In locally advanced rectal cancer the pathological complete response (pCR) to neoadjuvant chemoradiation therapy (nCRT) is associated with a favourable long-term prognosis. The identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. It has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. In addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. The main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.",[343],"Rectal Cancer","NOT_YET_RECRUITING","2024-09-25",{"date":347,"type":29},"2024-09-27",{"date":349,"type":20},"2024-10-03",{"date":351,"type":20},"2029-10-03",{"name":35,"class":36},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":45,"minAge":4,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":37},"100529917","incidence-and-characterization-of-drivers-oncogenes-in-the-population-with-lung-cancer-afferents-to-the-cancer-institute-in-aviano-inond-100529917","NCT06180005","Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)","Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D)","INOND","Inclusion Criteria:\n\n* First visit or first admission to CRO occurred in the period from September 2023 to September 2028\n* Diagnosis of NSCLC any stage\n\nExclusion Criteria:\n\n\\- Diagnosis of tumor not of certain lung origin (uncertain origin)",{"count":362,"type":20},700,"According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.",[365],"Non Small Cell Lung Cancer","2024-08-26",{"date":368,"type":29},"2024-08-27",{"date":370,"type":29},"2024-01-06",{"date":372,"type":20},"2039-12-30",{"name":35,"class":36},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":177,"phases":384,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100545207","phase-2-a-study-to-evaluate-the-combination-of-platinum-pemetrexed-based-chemotherapy-plus-lorlatinib-in-alk-positive-non-small-cell-lung-cancer-nsclc-with-exclusively-extracranial-disease-progression-on-lorlatinib-100545207","NCT06378892","A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib","A Multicenter Single-arm Phase II Interventional Study to Evaluate the Activity and Safety of the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib.","ALK-PPL","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.\n* Patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies.\n* Age at the time of signing the informed consent at least 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI).\n* Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as absence of CNS metastasis or CNS metastasis stable on Lorlatinib and\u002For stereotactic brain irradiation (SBRT).\n* Adequate organ function (kidney, bone marrow and liver).\n* Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC.\n* For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study drugs.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity reaction to one of the compounds or substances used in this protocol.\n* Diagnosis of any secondary malignancy within the last 3 years except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n* Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination.\n* Presence of toxicities contraindicating the continuation of therapy with Lorlatinib.\n* Concomitant use of potent CYP3A4\u002F5 inducers.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":383,"type":20},45,[385],"PHASE2","This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.",[388,389],"Non Small Cell Lung Cancer Metastatic","ALK Gene Mutation","2024-04-22",{"date":392,"type":29},"2024-04-23",{"date":306,"type":29},{"date":395,"type":20},"2028-05",{"name":35,"class":36},9,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":37},"100533723","patients-derived-organoids-as-a-promising-tool-to-tailor-ovarian-cancer-therapies-pandora-100533723","NCT06229522","Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).","Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA)","PANDORA","Inclusion Criteria:\n\n1. Signed informed consent form;\n2. Female sex;\n3. Age ≥18 years;\n4. Diagnosis of ovarian cancer;\n5. Availability of tumor sample or ascites that is planned to be stored in the Institutional Biobank for research purpose\n\nExclusion Criteria:\n\n1. Patients for which the tumor\u002Fascites biobanking process could compromise the diagnostic assessments;\n2. Pregnancy or breast-feeding\n3. History of concomitant or previous malignancy in the last 5 years",{"count":407,"type":20},150,"The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and\u002For promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.",[410],"Ovarian Cancer","2024-01-19",{"date":413,"type":29},"2024-01-29",{"date":327,"type":29},{"date":416,"type":20},"2037-12-31",{"name":35,"class":36},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":37},"100526608","the-theranostic-value-of-stard3-in-colorectal-cancer-the-star-study-100526608","NCT06136949","The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study","The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study: a Monocentric Observational Study","STAR","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of colorectal cancer, independently from diagnosis stage.\n* Age ≥18 years.\n* Signed informed consent form.\n* Availability of tissue and blood samples stored at the Institutional Biobank for research purposes.\n\nExclusion Criteria:\n\n* Patients for which the tumour biobanking process could compromise the diagnostic assessments.\n* Pregnancy or breast-feeding.\n* History of concomitant or previous malignancy in the previous 5 years, except for adequately treated cutaneous squamous cell carcinoma or surgically removed in situ cervical carcinoma.",{"count":407,"type":20},"This study aims at verifying the overexpression of STARD3 in both early and advanced CRC patients derived tissues, to identify the pathways underpinning tumorigenesis and cancer progression in which STARD3 is involved. Moreover its role as a dynamic biomarker of treatment response and its part in treatment sensitivity will be explored.",[429],"Colorectal Cancer",{"date":431,"type":29},"2023-11-18",{"date":433,"type":29},"2023-05-22",{"date":435,"type":20},"2032-12-31",{"name":35,"class":36},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":37},"100524888","a-study-to-develop-molecular-integrated-predictive-models-of-breast-radio-toxicity-precise-rtox-100524888","NCT06114589","A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)","An Observational Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)","(Precise-RTox)","Inclusion Criteria:\n\n* Age ≥18 years;\n* Ability to express appropriate informed consent to treatment;\n* Distant nonmetastatic breast cancer;\n* Histology: infiltrating NST(no special type)\u002Flobular carcinoma or ductal carcinoma in situ;\n* Stage: pTis; pT1-3 pN1-3 M0;\n* Hormone receptors, HER-2 status: Any;\n* Breast-conserving surgery. Both the sentinel lymph node biopsy and axillary lymphadenectomy. Negative surgical margins.\n* Candidates for postoperative radiation treatment.\n\nExclusion Criteria:\n\n* Refusal of radiotherapy treatment (i.e., absence of signed informed consent);\n* Previous radiation therapy at the same site;\n* Concomitant chemotherapy with anthracyclines or taxanes;\n* Inability to maintain treatment position;\n* Partial breast radiotherapy (PBI);\n* Male breast cancer;\n* Mastectomy surgery.",{"count":446,"type":20},420,"Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures may allow the risk of toxicity to be individualized. This would provide the clinician with a useful tool in order to personalize the radiation treatment, thus being able to choose the best technique or schedule for each patient.",[24],"2023-11-02",{"date":451,"type":29},"2023-11-07",{"date":453,"type":29},"2022-08-25",{"date":455,"type":20},"2026-06-30",{"name":35,"class":36},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":477},"100502081","vitamin-d-and-head-and-neck-cancer-impact-on-toxicity-and-prognosis-100502081","NCT05817617","Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis","Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis: Prospective Multicenter Study of Head-Neck Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO)","Inclusion Criteria:\n\nhistologically proven HNSCC (squamous cell carcinomas), all subsites\n\n* non-metastatic locally advanced stages\n* patients candidate for radical or adjuvant radiotherapy\n* patients candidate for bilateral neck irradiation\n* written informed consent\n\nExclusion Criteria:\n\n* distant metastases\n* patients with known disorders of calcium\u002Fvitamin D metabolism",{"count":465,"type":20},953,"The goal of this observational study is to learn about relation between vitamin D levels in subjects with head and neck cancer. The main question it aims to answer are:\n\n* variation of vitamin D levels in the study population at different time points\n* relation between therapy side effects and vitamin D level\n* relation between disease outcome and vitamin D level Participants will be followed as per clinical practice",[468],"Head and Neck Cancer","2023-10-24",{"date":471,"type":29},"2023-10-25",{"date":473,"type":29},"2021-08-08",{"date":475,"type":20},"2026-08",{"name":35,"class":36},10,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":37},"100521732","dietary-habits-nutritional-knowledge-and-physical-activity-assessment-in-early-stage-breast-cancer-patients-100521732","NCT06073418","Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients","Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)","DEMETRA","Inclusion Criteria:\n\n* Patients with surgically removed early stage (I-IIIa) hormone receptor-positive or hormone receptor negative breast cancer. Patients with hormone receptor-positive breast cancer can be in treatment with endocrine therapy; patients with hormone receptor-negative tumors have to be in follow-up. Concomitant use of targeted therapies with anti-hormonal agents is allowed only in adjuvant setting\n* Female patients ≥18 years of age.\n* Written informed consent must be obtained before any study-related assessment is performed\n\nExclusion Criteria:\n\n* Patients with advanced\u002Fmetastatic breast cancer.\n* Patients with early breast cancer receiving (neo)adjuvant chemotherapy or anti-HER2 agents\n* Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias)",{"count":487,"type":20},1098,"The advances in early detection coupled with improvements in treatments have led to an ever increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may complement the currently available treatment options. In particular, interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, and improve survival and the quality of life.This cross-sectional, prospective, observational study aims at evaluating dietary habits and nutritional knowledge in patients with early hormone receptor positive and hormone receptor negative breast cancer.",[24],"2023-10-05",{"date":492,"type":29},"2023-10-10",{"date":494,"type":29},"2022-10-28",{"date":496,"type":20},"2032-07-01",{"name":35,"class":36},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":177,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":37},"100520357","use-of-pulsed-low-dose-rate-re-irradiation-for-recurrent-glioma-pulsar-100520357","NCT06055517","Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)","A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)","PULSAR","Inclusion Criteria:\n\n* Age ≥18 years;\n* Ability to express appropriate informed consent to treatment;\n* Diagnosis of cerebral glioma;\n* Histological\u002Fradiological confirmation of disease recurrence\u002Frelapse;\n* Previous brain-level radiation therapy completed a minimum of 6 months;\n* Performance status: ECOG=0-2.\n\nExclusion Criteria:\n\n* Refusal to radiation treatment (i.e., absence of informed consent signed);\n* Concomitant chemotherapy;\n* Leptomeningeal spread of disease and localization in both cerebral hemispheres;\n* Current pregnancy.",{"count":507,"type":20},29,[179],"Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.",[322],"2023-09-20",{"date":513,"type":29},"2023-09-26",{"date":515,"type":29},"2023-05-26",{"date":517,"type":20},"2028-05-26",{"name":35,"class":36},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":37},"100518298","a-study-on-the-prevalence-of-clinically-useful-mutations-in-solid-tumor-characterized-by-next-generation-sequencing-methods-on-liquid-biopsy-analysis-popcorn-100518298","NCT06028724","A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","POPCORN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study have to meet all of the following criteria:\n\n* Patients, 18 years of age or older\n* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Histologically proven diagnosis solid tumor\n* Diagnosis of advanced or locally advanced disease\n* Patients candidated to receive standard therapy in the following line:\n* first, second or third-line therapy for colon-rectal cancer in IV stage\n* first or second-line therapy for gastric cancer in IV stage\n* primary intent or first-line therapy for pancreatic cancer\n* first-line therapy for bile duct cancer\n* first or second-line therapy for hepatocarcinoma\n* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage\n* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse\n* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)\n* first or second-line therapy for advanced or locally advanced cervical cancer\n* therapy for locally advanced or first line therapy for metastatic vulva cancer\n* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)\n\nExclusion Criteria:\n\n* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints",{"count":528,"type":20},782,"The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.",[531,532,533,534,140,535,536,537,24,410,119,538,539,540],"Solid Tumor","Advanced Solid Tumor","Locally Advanced Solid Tumor","Colon Rectal Cancer","Pancreatic Cancer","Bile Duct Cancer","Hepatocarcinoma","Cervical Cancer","Vulva Cancer","Melanoma","2023-09-08",{"date":543,"type":29},"2023-09-13",{"date":515,"type":29},{"date":546,"type":20},"2030-05-31",{"name":35,"class":36},""]