[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Oncology Ljubljana\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":556},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,47,76,101,129,159,185,209,230,249,272,296,320,343,363,383,406,431,449,469,490,509,530],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100639018","phase-4-adherence-and-safety-of-ribociclib-plus-aromatase-inhibitors-in-patients-with-early-stage-hr-and-her2--breast-cancer-100639018",false,"NCT07630948","Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer","Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, Hormonal Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer","riboADHERE","Inclusion Criteria:\n\n* Female or male patient prescribed with ribociclib in combination with an aromatase inhibitor independently of trial participation\n* Patient was prescribed ribociclib independently of this trial protocol and has not yet started cycle 1\n* Patient is ≥ 18 years-old at the time of ICF signature\n* Patient has mandatory Slovenian health insurance\n* Patient understands and speaks Slovenian language and is of congitive capability to participate in the trial\n* Patient has access to phone\n* Patient voluntarily agrees to participate in the trial and provides written ICF\n\nExclusion Criteria:\n\n* Patient is not treated with the combination of ribociclib and aromatase inhibitor for Early BC\n* Metastatic Hormone Receptor positive and HER2- negative BC\n* Any medical condition that, in the opinion of the investigator, would interfere with adherence participation in the trial (i.e. significant cognitive impairment, psychiatric condition)\n* Language barrier that precludes informed consent or meaningful participation in the adherence intervention","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Breast cancer is the most common malignancy in women, with HR+\u002FHER2- early breast cancer accounting for approximately 70% of cases. Although adjuvant endocrine therapy substantially reduces the risk of recurrence, a clinically meaningful proportion of patients, particularly those with intermediate- and high-risk disease, still experience relapse. The addition of CDK4\u002F6 inhibitors such as ribociclib to endocrine therapy has demonstrated significant improvement in invasive disease-free survival (iDFS) and is now part of standard adjuvant treatment for selected patients. However, the real-world effectiveness of prolonged oral therapy depends heavily on patient adherence, which may be negatively affected by treatment duration, adverse events, and the absence of immediate perceived benefit. Evidence regarding adherence to adjuvant ribociclib therapy in routine clinical practice remains limited. This study therefore aims to evaluate whether a structured adherence-support intervention can improve treatment adherence during ribociclib therapy and to explore the relationship between adherence and long-term clinical outcomes, including iDFS.",[27,28],"Breast Cancer","Adherence, Medication",[30,31,32,33],"HR+","HER2-","Early breast cancer","CDK4\u002F6 adherence","NOT_YET_RECRUITING","2026-06-03",{"date":37,"type":38},"2026-06-05","ACTUAL",{"date":40,"type":21},"2026-09-01",{"date":42,"type":21},"2032-09-01",{"name":44,"class":45},"Institute of Oncology Ljubljana","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100640742","phase-2-treatment-of-low-flow-vascular-malformations-with-bleomycin-electrosclerotherapy-best-100640742","NCT07579962","Treatment of Low-flow Vascular Malformations With Bleomycin Electrosclerotherapy (BEST)","BEST","Inclusion Criteria:\n\n* age ≥ 18\n* patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),\n* patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s),\n* longer lesion diameter not exceeding 25 cm.\n* more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,\n* skin or mucosal, superficial or deep-seated lesions can be treated,\n* technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible.\n\nExclusion Criteria:\n\n* pregnancy and lactation,\n* women of childbearing potential and men not using reliable contraception,\n* in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results\u002Fchest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated,\n* known allergy or hypersensitivity to bleomycin,\n* presence of significant central venous drainage precluding sclerotherapy,\n* acute lung infection or severely reduced lung function,\n* bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity,\n* ataxia telangiectasia,\n* chronic renal dysfunction.","99 Years",{"count":56,"type":21},140,[58],"PHASE2","In biomedical applications, electroporation is used not only for cancer treatment but also for vaccinations, treatment of cardiac arrhythmias and, more recently, for the treatment of vascular malformations. Bleomycin is a frequently used sclerosing agent in the treatment of various vascular malformations. The use of electrical pulses in addition to bleomycin increases the effectiveness of the treatment, similar to electrochemotherapy. Bleomycin electrosclerotherapy (BEST) is a new treatment modality that is effective in the treatment of low-flow malformations (venous and lymphatic malformations) and potentially also high-flow malformations (arteriovenous malformations). Although a limited number of reports have been published to date, more and more centers are using BEST for the treatment of vascular malformations. As part of the International Network for Sharing Practices on Electrochemotherapy (InspECT) consortium, a dedicated working group has been set up to develop standard operating procedures for BEST. Current Operating Procedures have been prepared and will be used in this clinical trial.",[61],"Vascular Malformations",[63,64,65,66,67],"vascular malformations","electroporation","bleomycin","electrosclerotherapy","low flow vascular malformations","2026-05-20",{"date":70,"type":38},"2026-05-22",{"date":72,"type":21},"2026-06-30",{"date":74,"type":21},"2032-06-30",{"name":44,"class":45},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100634512","phase-2-prophylactic-radiotherapy-to-prevent-bone-complications-in-patients-with-metastatic-solid-cancers-100634512","NCT07540650","Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","pRevenT","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)\n* Presence of up to five high-risk bone metastases\n* High-risk bone metastases defined according to protocol criteria\n* Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)\n* ECOG performance status 0-2\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the index bone metastases preventing safe treatment planning\n* Symptomatic bone metastases requiring immediate palliative radiotherapy\n* Evidence of spinal cord compression\n* Bone metastases causing significant pain requiring opioid analgesics\n* Oligometastatic disease suitable for radical treatment\n* Leptomeningeal disease\n* ECOG performance status ≥3\n* Life expectancy less than 3 months\n* Any condition that, in the investigator's opinion, would interfere with study participation or assessment",{"count":20,"type":21},[58],"This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.",[88,89],"Bone Metastases","Metastatic Solid Tumor",[91,92],"prophylactic radiotherapy","early radiotherapy","2026-04-14",{"date":95,"type":38},"2026-04-20",{"date":97,"type":21},"2026-04",{"date":99,"type":21},"2029-02",{"name":44,"class":45},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":46},"100626189","phase-2-effect-of-perioperative-lidocaine-or-high-dose-dexamethasone-on-immune-response-in-colon-cancer-surgery-pildi-study-100626189","NCT07432399","Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)","Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on the Immune Response in Patients Undergoing Surgery for Colon Cancer - The PILDI Study","PILDI","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Histologically confirmed colon cancer\n* Scheduled for elective surgical resection of colon cancer\n* Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients\n* Severe hepatic impairment\n* Severe renal impairment\n* Severe cardiac conduction disorders or clinically significant arrhythmias\n* Pregnancy or breastfeeding\n* Severe uncontrolled comorbidities that could interfere with study participation\n* Participation in another interventional clinical trial that could influence study outcomes\n* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation",{"count":110,"type":21},100,[58],"This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.",[114,115,116],"Colon Cancer","Colorectal Cancer","Perioperative Immune Response",[107,118,119],"Lidocaine","Intravenous Lidocaine","RECRUITING","2026-03-04",{"date":123,"type":38},"2026-03-06",{"date":125,"type":38},"2025-09-01",{"date":127,"type":21},"2027-05-01",{"name":44,"class":45},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":137,"minAge":18,"maxAge":54,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100566072","adherence-to-aromatase-inhibitors--abemaciclib-treatment-in-patients-with-early-stage-her2-negative-breast-cancer-100566072","NCT06650423","Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer","ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer","ONCO-Adher","Inclusion Criteria:\n\n* Female,\n* Early HR+\u002FHER-2- BC,\n* Patient is receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole or exemestane), with or without a CDK4\u002F6 inhibitor abemaciclib, for no more than 18 months,\n* Treatment of BC is being conducted at OIL,\n* Patient has mandatory health insurance through Health Insurance Institute of Slovenia,\n* Patient understands Slovenian language, and\n* Patient agrees to participate in the study and provides written informed consent.\n\nExclusion Criteria:\n\n* Metastatic HR+\u002FHER2-negative breast cancer\n* Previous treatment for breast cancer with an aromatase inhibitor, with or without a CDK4\u002F6 inhibitor, for early breast cancer prior to the current adjuvant treatment line","FEMALE",{"count":139,"type":21},319,"OBSERVATIONAL","Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+\u002FHER2-). Despite advancements in adjuvant endocrine therapy, 20-30% of early-stage breast cancer patients relapse within the first decade post-surgery. A recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4\u002F6 inhibitors (CDK4\u002F6 inhibitors). Abemaciclib and ribociclib were assessed in the adjuvant setting, both showing improvement in invasive disease-free survival (IDFS). Abemaciclib has been approved by the FDA and EMA for HR+\u002FHER2- early breast cancer at high risk of disease recurrence and is the first addition to the Slovenian treatment regimen in routine clinical practice.\n\nPoor medication adherence can directly affect the effectiveness of treatment for early HR+\u002FHER2- breast cancer. While adherence data in patients treated with aromatase inhibitors are available, the adherence rate in patients with early HR+\u002FHER2- breast cancer taking abemaciclib remains unclear.\n\nIn this study, investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have lower medication adherence and higher discontinuation rates compared to those receiving aromatase inhibitors alone. It is expected that patients with better quality of life, better cognitive functioning, and a more positive attitude toward their therapy will demonstrate higher medication adherence rates. Adherence may also be influenced by additional factors, such as age and prior treatments.",[143,144,145],"Early Breast Cancer","Hormone Receptor Positive Tumor","HER2-negative Breast Cancer",[147,148,149,30,31,150,151,152],"breast cancer","medication adherence","CDK4\u002F6","aromatase inhibitor","quality of life","medication belief",{"date":123,"type":38},{"date":155,"type":38},"2025-01-05",{"date":157,"type":21},"2027-03-01",{"name":44,"class":45},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":46},"100627044","cognitive-impairment-in-patients-with-diffuse-large-b-cell-lymphoma-100627044","NCT07443514","Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma","Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Newly diagnosed diffuse large B-cell lymphoma (DLBCL) planned for treatment with systemic chemotherapy (R-CHOP) with or without intrathecal chemotherapy\n* Ability to provide written informed consent\n* For healthy volunteer\u002Fcontrol group: relatives of participating patients willing to undergo cognitive testing and questionnaires\n\nExclusion Criteria:\n\n* Severe cognitive impairment preventing completion of neurocognitive testing\n* Severe psychiatric disorder or neurological disease interfering with cognitive assessment\n* Inability to understand study procedures or complete questionnaires\n* Refusal or inability to provide informed consent",true,{"count":168,"type":21},3,[170],"NA","This prospective, non-randomized diagnostic interventional study evaluates cognitive impairment in patients with diffuse large B-cell lymphoma (DLBCL) treated at the Institute of Oncology Ljubljana. Chemotherapy regimens are administered according to clinical indication and are not assigned by the study protocol.\n\nThe research intervention consists of structured neurocognitive assessments and biomarker analyses performed at predefined time points during treatment and follow-up. Cognitive function will be assessed at baseline, after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, cerebrospinal fluid (CSF) biomarkers will be analyzed using samples collected during clinically indicated lumbar punctures.\n\nThe study aims to characterize the frequency, severity, and trajectory of cognitive impairment and to identify clinical and biological predictors of treatment-associated cognitive changes in patients with DLBCL.",[173],"Diffuse Large B-Cell Lymphoma",[175,176],"Diffuse large B-cell lymphoma","Chemotherapy-related cognitive impairment","2026-02-27",{"date":179,"type":38},"2026-03-02",{"date":181,"type":38},"2022-01-01",{"date":183,"type":21},"2026-12-31",{"name":44,"class":45},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":137,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":46},"100627041","phase-2-electrochemotherapy-for-recurrent-vulvar-cancer-100627041","NCT07443475","Electrochemotherapy for Recurrent Vulvar Cancer","Use of Electrochemotherapy in Women With Vulvar Cancer","Inclusion Criteria:\n\n* Local recurrence of vulvar cancer\n* Age ≥ 18 years\n* Expected life expectancy \\> 3 months\n* Karnofsky performance status ≥ 70 or WHO performance status ≤ 2\n* At least 2 weeks since last treatment\n* Ability to understand the procedure and possible adverse effects\n* Ability to provide written informed consent\n* Patient discussed at multidisciplinary tumor board before enrollment\n* Fit for anesthesia\n\nExclusion Criteria:\n\n* Life-threatening infection and\u002For severe cardiac, hepatic, or other systemic disease\n* Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)\n* Age \\\u003C 18 years\n* Major coagulation disorders not responding to standard therapy\n* Prior cumulative bleomycin dose ≥ 400 mg\u002Fm²\n* Chronic renal impairment (creatinine \\> 150 µmol\u002FL)\n* Epilepsy\n* Pregnancy\n* Inability to understand the study or refusal to participate",{"count":193,"type":21},13,[58],"This phase I\u002FII interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.",[197,198],"Vulvar Cancer","Recurrent Vulvar Cancer",[200,201,202],"Electrochemotherapy","Bleomycin","Vulvar carcinoma",{"date":179,"type":38},{"date":205,"type":38},"2021-09-01",{"date":207,"type":21},"2026-08-31",{"name":44,"class":45},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":229},"100625960","sbrt-technique-implementation-for-spinal-metastases-irradiation-100625960","NCT07429422","SBRT Technique Implementation for Spinal Metastases Irradiation","Program SBRT Technique Implementation in Spinal Metastases Irradiation","Inclusion Criteria:\n\n* Adult patients (≥18 years) with spinal metastases or spinal tumors referred for stereotactic body radiotherapy (SBRT).\n* Patients eligible for SBRT treatment according to the institutional SBRT spine protocol.\n* Ability to undergo CT simulation, immobilization, and image-guided radiotherapy procedures.\n\nExclusion Criteria:\n\n* Inability to tolerate SBRT positioning or immobilization.\n* Clinical situations requiring urgent surgical intervention or alternative treatment.\n* Other medical conditions that prevent safe SBRT delivery.",{"count":110,"type":21},[170],"Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision.\n\nThe Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety.\n\nThis clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.",[220,221,88],"Spinal Metastases","Spinal Tumors","2026-02-20",{"date":224,"type":38},"2026-02-24",{"date":226,"type":38},"2021-11-01",{"date":183,"type":21},{"name":44,"class":45},2,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":46},"100624976","web-based-application-for-monitoring-radiation-therapy-complications-in-cancer-patients-100624976","NCT07416630","Web-Based Application for Monitoring Radiation Therapy Complications in Cancer Patients","Programme for Development and Use of a Web-based Application for Monitornig Complications of Radiation Therapy in Cancer Patients and Analysis of Its Effectiveness","Inclusion Criteria:\n\n* Patients receiving radiotherapy for gynecologic cancer, urologic cancer, or breast cancer at the Institute of Oncology Ljubljana.\n* Ability to access and use the web-based application on a smartphone, computer, or tablet.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Inability to understand the questionnaire questions and provide meaningful answers.",{"count":238,"type":21},30,[170],"Cancer treatment is multidisciplinary and may include radiotherapy. Treatment-related complications represent a burden for patients and the healthcare system. Early recognition of radiotherapy-related side effects is important for timely clinical interventions and improved quality of care. This study aims to improve comprehensive patient management during and after radiotherapy through development and implementation of a web-based application using standardized electronic patient-reported outcome questionnaires (PROMs). Patients will report radiotherapy-related symptoms and quality of life through web-based questionnaires that will be securely transmitted to the Institute of Oncology Ljubljana for review by healthcare professionals. Responses will be categorized using a traffic-light system to guide clinical actions and optimize follow-up visits.",[242,243,27],"Gynecologic Cancer","Urologic Cancer",{"date":224,"type":38},{"date":246,"type":38},"2023-09-02",{"date":183,"type":21},{"name":44,"class":45},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":46},"100624051","electrochemotherapy-induced-changes-in-tumor-microenvironment-in-cutaneous-melanoma-100624051","NCT07404605","Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma","Electrochemotherapy Induces Changes in Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Histologically confirmed cutaneous melanoma\n* Presence of cutaneous and\u002For subcutaneous metastases eligible for electrochemotherapy\n* Candidate for electrochemotherapy with intravenous bleomycin or intratumoral cisplatin according to standard clinical practice\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)\n* Pregnancy or breastfeeding\n* Severe comorbidities preventing electrochemotherapy\n* Inability to comply with study procedures",{"count":257,"type":21},150,[170],"Cutaneous melanoma frequently develops cutaneous and subcutaneous metastases, which may cause significant morbidity and negatively affect quality of life. Electrochemotherapy (ECT) is an established local treatment modality for cutaneous and subcutaneous tumor lesions that combines the administration of cytotoxic drugs with the application of electric pulses to increase drug uptake into tumor cells.\n\nIn addition to its direct cytotoxic effects, electrochemotherapy may induce changes in the tumor microenvironment, including immune cell infiltration, vascular alterations, and other biological responses that could influence tumor control.\n\nThe aim of this study is to evaluate changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases following electrochemotherapy with either intravenous bleomycin or intratumoral cisplatin. Tumor tissue samples collected before and after treatment will be analyzed to characterize microenvironmental changes and to compare treated and untreated lesions.\n\nThe results of this study may improve understanding of biological effects of electrochemotherapy in melanoma metastases and support further development of treatment strategies.",[261,262],"MELANOMA","SKIN NEOPLASMS",[261],"2026-02-17",{"date":266,"type":38},"2026-02-19",{"date":268,"type":38},"2023-09-01",{"date":270,"type":21},"2026-09-30",{"name":44,"class":45},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":46},"100625843","quality-of-life-in-colorectal-cancer-survivors-100625843","NCT07427901","Quality Of Life In Colorectal Cancer Survivors","Inclusion Criteria:\n\n* Patients with colorectal cancer (colon or rectal cancer)\n* Age 25 to 65 years\n* First oncological treatment performed at the Institute of Oncology Ljubljana\n* Working-capable patients\n* Ability to complete questionnaires\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 25 years or \\> 65 years\n* Patients unable to complete questionnaires\n* Patients unable to participate in follow-up assessments\n* Patients who do not provide written informed consent",{"count":279,"type":21},368,[170],"The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study aims to assess quality of life in colorectal cancer survivors in relation to psycho-physical-social well-being at different time points and to evaluate the prevalence of late adverse effects and their association with diagnosis and specific oncological treatment.",[115,114,283],"Rectal Cancer",[285,286,287],"Quality of Life","Cancer Survivors","Late Adverse Effects","2026-02-16",{"date":290,"type":38},"2026-02-23",{"date":292,"type":38},"2023-05-01",{"date":294,"type":21},"2027-12-31",{"name":44,"class":45},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":311,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":46},"100625450","anabolic-response-to-intravenous-amino-acids-in-chronic-intestinal-failure-patients-100625450","NCT07422792","Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients","Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure","Inclusion Criteria:\n\n\\- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.",{"count":304,"type":21},40,[170],"The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.",[308,309,310],"Chronic Intestinal Failure","Intestinal Failure","Home Parenteral Nutrition",[312,313],"Parenteral Nutrition","Intravenous Amino Acids","2026-02-13",{"date":222,"type":38},{"date":317,"type":38},"2022-04-01",{"date":294,"type":21},{"name":44,"class":45},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":46},"100625449","immunotherapy-efficacy-and-pd-l1-as-a-predictive-biomarker-in-metastatic-melanoma-in-slovenia-100625449","NCT07422779","Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia","Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood","MAK","Inclusion Criteria:\n\n* Age ≥18 years\n* Cytologically or histologically confirmed metastatic malignant melanoma\n* Stage IIID unresectable or stage IV (AJCC 8th edition)\n* ECOG performance status 0-2\n* First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab\u002Fnivolumab)\n* CT\u002FPET-CT performed within 4 weeks prior to treatment start\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous systemic therapy for melanoma\n* ECOG performance status 3-4\n* Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)\n* Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence \\>3 years)",{"count":110,"type":21},[170],"The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.",[332,333],"Metastatic Melanoma","Skin Cancer",[335,336],"Immunotherapy","Immune Checkpoint Inhibitors",{"date":222,"type":38},{"date":339,"type":38},"2022-03-01",{"date":341,"type":21},"2028-03-31",{"name":44,"class":45},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":46},"100624248","efficacy-of-first-line-immunotherapy-in-metastatic-melanoma-in-slovenia-and-identification-of-predictive-biomarkers-100624248","NCT07407166","Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers","Efficacy of Immunotherapy in the First Line of Treatment of Diffuse Melanoma in Slovenia and Recognition of Prognostic and Predictive Biomarkers From Primary Tumor, Faeces and Body Fluids","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Metastatic (diffuse) melanoma\n* Planned first-line immunotherapy treatment\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Inability to provide informed consent\n* Any condition preventing participation or sample collection according to investigator judgment",{"count":304,"type":21},[170],"This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy.\n\nBiological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET\u002FCT) will be performed before treatment initiation and during follow-up to evaluate response.\n\nThe study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.",[332,354],"Melanoma",[335,356],"First-Line Treatment","2026-02-12",{"date":264,"type":38},{"date":360,"type":38},"2021-05-01",{"date":294,"type":21},{"name":44,"class":45},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":382,"locationsCount":46},"100624253","combined-chemotherapy-and-ablative-radiotherapy-sbrt-as-first-line-treatment-in-locally-advanced-inoperable-pancreatic-cancer-sbrt-panc-100624253","NCT07407231","Combined Chemotherapy And Ablative Radiotherapy (SBRT) As First-Line Treatment In Locally Advanced Inoperable Pancreatic Cancer (SBRT-PANC)","Efficacy Of Combination Chemotherapy And Ablative Radiotherapy (SBRT) In The First-Line Treatment Of Locally Advanced Inoperable Pancreatic Cancer","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Locally advanced, inoperable pancreatic cancer\n* Treated with first-line systemic chemotherapy followed by stereotactic body radiotherapy (SBRT) at participating centers\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Metastatic pancreatic cancer\n* Prior systemic therapy for locally advanced pancreatic cancer (one or more previous lines of systemic treatment)\n* Disease progression after initial chemotherapy prior to SBRT\n* Any condition that, in the investigator's opinion, would interfere with study participation or evaluation",{"count":371,"type":21},18,[170],"This prospective interventional clinical study evaluates the efficacy and safety of combining systemic chemotherapy followed by ablative stereotactic body radiotherapy (SBRT) as first-line treatment in adult patients with locally advanced, inoperable pancreatic cancer.\n\nThe study aims to determine the response rate after SBRT delivered following initial chemotherapy, as well as time to disease progression and treatment-related toxicity. Patients receive standard first-line chemotherapy and, in the absence of disease progression, undergo ablative SBRT to the primary tumor, followed by continuation of systemic therapy according to clinical practice.\n\nThe study is conducted in Slovenia, with patient enrollment expanded to additional participating clinical centers following an approved amendment.",[375],"Locally Advanced Pancreatic Cancer",[377,378],"SBRT","Stereotactic Body Radiotherapy",{"date":264,"type":38},{"date":205,"type":38},{"date":183,"type":21},{"name":44,"class":45},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":46},"100624045","bioelectrical-impedance-analysis-for-perioperative-fluid-evaluation-in-colorectal-cancer-surgery-100624045","NCT07404527","Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery","Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery","Inclusion Criteria:\n\nAdult patients (≥18 years of age).\n\nHistologically confirmed head and neck cancer.\n\nIndication for induction chemotherapy followed by chemoradiotherapy with cetuximab.\n\nAdequate organ function as required by the study protocol.\n\nAbility to provide informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy or radiotherapy for head and neck cancer.\n\nPresence of uncontrolled comorbidities that would preclude study treatment.\n\nKnown hypersensitivity to cetuximab or components of the treatment regimen.\n\nPregnancy or breastfeeding.",{"count":391,"type":21},60,[170],"Sarcopenia is a complex syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength. In patients with cancer, sarcopenia is associated with poorer prognosis, increased treatment-related toxicity, higher postoperative complication rates, reduced response to therapy, and decreased quality of life. Importantly, sarcopenia may be present even in patients with preserved nutritional status or overweight.\n\nPatients with gastrointestinal cancers are at particularly high risk of developing sarcopenia, both as a consequence of the malignant disease itself and as a result of systemic anticancer treatment. Early identification of patients at risk is therefore essential in order to enable timely nutritional and supportive interventions.\n\nThe aim of this study is to evaluate the proportion of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire before the start of systemic treatment and during treatment. Patients with a positive screening result will be referred for further clinical nutritional assessment and managed according to a multidisciplinary approach.",[395,396],"Gastrointestinal Cancer","Digestive System Neoplasms",[398],"SARC-F","2026-02-11",{"date":314,"type":38},{"date":402,"type":38},"2023-10-24",{"date":404,"type":21},"2026-03-31",{"name":44,"class":45},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":137,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":46},"100625091","studying-the-role-of-circulating-tumor-cell-clusters-in-patients-with-high-risk-early-breast-cancer-study-galia-100625091","NCT07418125","Studying the Role of Circulating Tumor Cell Clusters in Patients With High-risk Early Breast Cancer, Study GALIA","GALIA","Inclusion Criteria:\n\n* Patients with inflammatory breast cancer, regardless of cancer subtype (stage IIID)\n* Patients with non-inflammatory breast cancer: triple-negative and HER2+ subtypes, from stage IIB to IIIA-C\n* Adequate health status for neoadjuvant systemic treatment\n\nExclusion Criteria:\n\n* Inflammatory breast cancer stage IV\n* Luminal A, luminal B subtypes of non-inflammatory breast cancer\n* Stages I-IIA breast cancer\n* Inability to understand or communicate in Slovenian\n* Inability to follow protocol instructions\n* Inappropriate health status for chemotherapy treatment\n* Primary treatment with surgery",{"count":414,"type":21},130,[170],"CTCs, CTC clusters, and ctDNA may predict treatment response and survival in high-risk breast cancer, including IBC.",[27],[147,419,420,421,422],"ctDNA","liquid biopsy","circulating tumor cell","circulating tumor cluster","2026-02-10",{"date":425,"type":38},"2026-02-18",{"date":427,"type":38},"2024-02-07",{"date":429,"type":21},"2028-12-31",{"name":44,"class":45},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":107,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":229},"100587084","phase-2-effect-of-perioperative-intravenous-infusion-of-lidocaine-on-the-postoperative-course-and-the-immune-response-in-patients-undergoing-surgery-for-colon-cancer---the-pildi-study-100587084","NCT06923787","Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study","Inclusion Criteria:\n\n* colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,\n* age of patients between 18 and 80 years,\n* low to moderate risk of anesthesia (ASA up to and including 3),\n* ability to understand the study and to sign an informed consent to participate in the study\n\nExclusion Criteria:\n\n* patients receiving neoadjuvant chemotherapy,\n* pregnancy or breastfeeding,\n* known allergy to lidocaine\n* cardiac rhythm disturbances (bradycardia \\\u003C 45 beats\u002Fmin, complete heart block, use of group III antiarrhythmics),\n* status post cardiac arrest,\n* porphyria,\n* myasthenia gravis,\n* severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),\n* renal disease (hamodialysis, creatinine clearance \\\u003C30 mL\u002Fmin),\n* epilepsy,\n* active infection,\n* presence of viral or systemic fungal disease,\n* uncontrolled psychotic state,\n* ulcerative gastric or duodenal disease,\n* chronic corticosteroid therapy.","80 Years",{"count":110,"type":21},[58],"There are very few data in the literature on changes in inflammatory markers when lidocaine is administered perioperatively in patients with colorectal cancer. In patients undergoing surgery for colon cancer, the aim is to conduct a double-blind placebo-controlled study to determine differences in levels of pro-inflammatory markers, postoperative pain and opioid analgesic consumption in the first two days after surgery, and the time to first postoperative bowel movement. Groups of patients receiving perioperative lidocaine infusion, high dose dexamethasone or placebo will be compared.",[114],"2026-02-03",{"date":444,"type":38},"2026-02-05",{"date":442,"type":38},{"date":447,"type":21},"2028-07-01",{"name":44,"class":45},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":137,"minAge":18,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":46},"100565897","molecular-biomarkers-of-response-to-radiation-therapy-in-breast-cancer-100565897","NCT06648148","Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer","Inclusion Criteria:\n\n* Breast cancer patients with DCIS with an indication for adjuvant radiation therapy\n\nExclusion Criteria:\n\n* Any specific systemic oncological therapy","75 Years",{"count":457,"type":21},200,"The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.",[27,460],"Radiotherapy Side Effect","2024-10-16",{"date":463,"type":38},"2024-10-18",{"date":465,"type":38},"2019-11-01",{"date":467,"type":21},"2029-12-31",{"name":44,"class":45},{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":437,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":46},"100520778","determination-of-copper-and-other-trace-elements-in-serum-samples-from-patients-with-biliary-tract-cancers-100520778","NCT06060990","Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers","Inclusion Criteria:\n\n* aged ≥18 years\n* cytologically or histologically verified biliary tract cancer\n* no prior systemic therapy and no radiation therapy for advanced, inoperable or metastatic disease\n* WHO performance status 0 - 2 (ECOG criteria)\n* imaging diagnosis (CT of thoracic and abdominal organs) performed within 4 weeks prior to the first administration of systemic therapy\n* disease measurable by RECIST or ECOG criteria\n* signed Consent to Participate in Clinical Research form\n\nExclusion Criteria:\n\n* prior systemic treatment and radiation therapy for inoperable, metastatic disease\n* WHO performance status \\> 2 (ECOG criteria)\n* contraindications to immunotherapy (known immunodeficiency or active immunosuppressive therapy or active autoimmune disease requiring treatment)\n* other malignancies, except cured basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or other cured solid tumours without recurrence ≥ 3 years after treatment.",{"count":476,"type":21},20,[170],"The aim of the study is to determine the total concentration of selected trace elements (Cu, Zn, Fe), the proportion of free Cu and Cu bound to ceruloplasmin and the isotopic ratio of Cu65\u002FCu63 in blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based methods. The results will be statistically evaluated and the potential applications of the analytical methods used in cancer diagnosis and therapy will be assessed.",[480],"Trace Element Deficiency",[482],"metastatic biliary tract cancer, biomarkers, trace elements",{"date":484,"type":38},"2024-10-17",{"date":486,"type":38},"2023-01-01",{"date":488,"type":21},"2026-01-01",{"name":44,"class":45},{"id":491,"slug":492,"hasResults":11,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":46},"100506791","biomarkers-in-immunotherapy-of-melanoma-100506791","NCT05878977","Biomarkers in Immunotherapy of Melanoma","Effectiveness of Immunotherapy in the First-line Treatment of Disseminated Melanoma and Recognition of Prognostic and Predictive Biomarkers From the Primary Tumor, Stool and Body Fluids: PROTOCOL TRIAL","Inclusion Criteria:\n\n* Age over 18 years\n* Cytologically or histologically verified malignant melanoma\n* Stage IIID unresectable\u002FIV according to AJCC classification (8th edition, 2018)\n* Performance status according to WHO 0 - 2 (ECOG criteria)\n* 1st line of systemic treatment with immunotherapy (nivolumab, ipi\u002Fnivo, pembrolizumab)\n* Triple CT\u002FPET CT done within 4 weeks before the first application\n* Signed consent to participate in clinical research\n\nExclusion Criteria:\n\n* Previously treated melanoma with systemic therapy\n* Capacity status according to WHO 3 - 4 (ECOG criteria)\n* Contraindications for immunotherapy treatment (known deficiency of the immune system or active immunosuppressive treatment or active autoimmune disease requiring treatment)\n* Other malignant diseases (except cured basal cell carcinoma and squamous cell carcinoma)",{"count":257,"type":21},[170],"Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study. Stool samples are submitted before the start of treatment, at the 12 (+\u002F-2) week and 28 (+\u002F-4) week, and at the event ( such as, suspected disease progression\u002Fhyperprogressio, immune related adverse event (irAE), etc). Peripheral venous blood samples are taken additionaly at the same time points for cytologic and molecular tests. Histological material from the tumor tissue is obtained before the start of immunotherapy treatment. Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predict response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma at different time points. Response is evaluated radiologically with imaging methods in accordance with the irRECIST criteria. Conclussion: Despite the great success of the treatment of metastatic melanoma with immunotherapy, there remains a significant proportion of patients who do not respond to treatment or who develop severe adverse events during treatment. Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response is therefore necessary. This study is the first to combine and investigate multiple potential predictive and prognostic biomarkers and its dynamics. The results could serve for a better and multi-level understanding of the various factors influencing immunotherapy treatment.",[332,501,502,503],"Immune Checkpoints Inhibitors","Gastrointestinal Microbiome (Bacterial and Viral)","Exosomal mRNA Expression of PD-L1 and IFNγ",{"date":463,"type":38},{"date":506,"type":38},"2022-10-05",{"date":294,"type":21},{"name":44,"class":45},{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":137,"minAge":18,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":46},"100420866","phase-2-electrochemotherapy-of-gynecological-cancers-100420866","NCT04760327","Electrochemotherapy of Gynecological Cancers","GynECT","Inclusion Criteria:\n\n1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.\n2. Age more than 18.\n3. Life expectancy more than 3 month.\n4. Performance status Karnofsky ≥ 70 or WHO \\\u003C or 2.\n5. Treatment free interval minimum 2 weeks.\n6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.\n7. Patient must give informed consent.\n8. Patient must be discussed at the multidisciplinary team before entering the trial.\n9. Patient should be suitable for anesthesia.\n\nExclusion Criteria:\n\n1. Visceral, bone or diffuse metastases.\n2. Life-threatening infection and\u002For heart failure and\u002For liver failure and\u002For other severe systemic pathologies.\n3. Significant reduction in respiratory function.\n4. Age less than 18 years.\n5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).\n6. Cumulative dose of ≥ 400 mg\u002Fm2 bleomycin received.\n7. Impaired kidney function (creatinin \\> 150 µmol\u002Fl).\n8. Patients with epilepsy.\n9. Pregnancy.\n10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.","105 Years",{"count":238,"type":21},[58],"To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and\u002For regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.",[521],"Gynecological Cancers",[200,523,201],"Cisplatin",{"date":484,"type":38},{"date":526,"type":38},"2020-07-01",{"date":528,"type":21},"2025-12-31",{"name":44,"class":45},{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":46},"100443481","phase-2-consolidation-versus-induction-chemotherapy-in-total-neoadjuvant-therapy-of-rectal-cancer-with-high-risk-for-recurrence-100443481","NCT05054959","Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence","Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)","ICONA","Inclusion Criteria:- histologically proven rectal adenocarcinoma\n\n* no distant metastases on CT scan (M0 disease)\n* at least one high risk factor for disease recurrence identified on MR imaging:\n\n  * T4 tumor (cT4)\n  * N2 disease (cN2)\n  * extramural venous invasion (cEMVI+)\n  * positive lateral lymph nodes\n  * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)\n* capacity for informed consent\n* willingness to attend regular check-ups during and after treatment\n\nExclusion Criteria:history of previous irradiation in the pelvic area\n\n* absolute contraindications for MR imaging\n* distant metastases cannot be reliably excluded\n* synchronous cancer\n* chronic inflammatory bowel disease",{"count":539,"type":21},62,[58],"The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence",[543],"Locally Advanced Rectal Cancer",[545,546,547,548],"rectal cancer","total neoadjuvant therapy","induction chemotherapy","consolidation chemotherapy","2021-09-19",{"date":551,"type":38},"2021-09-23",{"date":553,"type":38},"2021-06-24",{"date":294,"type":21},{"name":44,"class":45},""]