[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto de Investigación Biomédica de Salamanca\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":388},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,47,77,101,128,157,185,213,241,266,293,318,341,365],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100614268","plasma-host-microbe-proteomics-to-predict-complications-in-high-risk-febrile-neutropenia-100614268",false,"NCT07277387","Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia","A Multicenter Prospective Observational Study on the Plasma Proteomic Profiling of Human and Microbial Proteins for the Early Identification of Biomarker Combinations (Combitypes) Associated With Complications in Oncohematologic Patients With Febrile Neutropenia","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Written informed consent provided by patient or legal representative.\n* Diagnosis of hematologic malignancy under induction chemotherapy, post-allogeneic hematopoietic stem cell transplantation, or CAR-T therapy.\n* High-risk febrile neutropenia (ANC ≤ 100 cells\u002Fmm³, expected duration ≥ 7 days, or significant comorbidities).\n* Fever defined as oral temperature ≥38.3 °C once or ≥38.0 °C for ≥1 hour.\n* Hospitalized or requiring immediate admission at the time of FN diagnosis.\n\n  ´- Initial uncomplicated clinical presentation, with no previous infection or colonization by multidrug-resistant bacteria.\n* Eligible for initial monotherapy with broad-spectrum empirical antibiotic.\n* Availability for serial plasma sampling and clinical follow-up.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Low-risk FN according to MASCC\u002FCISNE criteria.\n* Initial sample collected after antibiotic administration.\n* Decline or inability to provide informed consent.\n* Any condition preventing safe participation or reliable sample collection.\n* Fever induced by noninfectious causes (considered as adjustment factor, not exclusion).","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","30 Days","OBSERVATIONAL","Febrile neutropenia (FN) is a common oncologic emergency in patients with hematologic malignancies, associated with high morbidity and mortality. Early identification of patients at higher risk of complications such as sepsis or septic shock is critical to optimize antimicrobial management.\n\nThis study aims to characterize the human and microbial plasma proteome using high-resolution mass spectrometry to identify biomarker combinations (\"combitypes\") capable of predicting complications in oncohematologic patients with FN.\n\nA cohort of 350 adult patients with high-risk FN and initially uncomplicated clinical presentation will be enrolled across three tertiary hospitals. Plasma samples will be collected at fever onset (before antibiotic initiation) and after 48 hours. Proteomic data will be integrated with clinical information using multivariate and machine learning models to develop a predictive model for complications.",[25],"Febrile Neutropenia",[27,28,29,30,31,32,33],"febrile neutropenia","hematologic malignancy","proteomics","sepsis","biomarkers","septic shock","mass spectrometry","RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2026-06-09",{"date":42,"type":20},"2029-01",{"name":44,"class":45},"Instituto de Investigación Biomédica de Salamanca","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100623296","effectiveness-of-a-physical-exercise-prescription-program-in-primary-care-for-adults-aged-65-and-older-prefis-ap-100623296","NCT07394790","Effectiveness of a Physical Exercise Prescription Program in Primary Care for Adults Aged 65 and Older: PREFIS-AP","Effectiveness of a Physical Exercise Prescription Program in Primary Care to Improve Physical Fitness and Quality of Life in Adults Aged 65 Years and Older in a Rural Health Area: PREFIS-AP Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Motivated to participate and able to provide informed consent\n* Able to attend baseline assessment and follow-up\n* Clinical stability allowing participation in exercise evaluation\n\nExclusion Criteria:\n\n* Recent myocardial infarction\n* Unstable angina\n* Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)\n* Syncope\n* Acute endocarditis, myocarditis, or pericarditis\n* Severe or symptomatic aortic stenosis\n* Uncontrolled heart failure\n* Recent pulmonary thromboembolism or pulmonary infarction\n* Lower-limb thrombosis\n* Severe aortic stenosis or suspected dissecting aortic aneurysm\n* Uncontrolled asthma\n* Pulmonary edema\n* Acute respiratory failure\n* Acute non-cardiopulmonary illness that impairs exercise capacity (e.g., infection, thyrotoxicosis, acute renal failure)\n* Mental disorder that prevents adequate cooperation.",true,"65 Years",{"count":57,"type":20},210,"INTERVENTIONAL",[60],"NA","This randomized controlled trial aims to evaluate the effectiveness of an individualized Physical Exercise Prescription Program delivered in Primary Care for adults aged 65 years and older. The intervention includes a structured assessment of physical fitness, muscle function and mass, physical activity level, and quality of life, followed by a tailored exercise plan encompassing aerobic, strength, respiratory, flexibility, and balance training. Outcomes will be compared with a control group receiving standard health advice to walk briskly for at least 30 minutes daily. The study also explores associations between polypharmacy, muscle function, physical performance, and quality of life.",[63],"Sedentary Lifestyle",[65,66,67],"aging","sarcopenia","Reduced physical fitness","2026-04-22",{"date":70,"type":38},"2026-04-27",{"date":72,"type":38},"2026-02-09",{"date":74,"type":20},"2026-12",{"name":44,"class":45},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100591197","evaluation-of-a-diagnostic-software-for-coronary-artery-disease-using-retrospective-ccta-data-codex-1-study-100591197","NCT06977295","Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)","CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study","CODEX1","Inclusion Criteria:\n\n* Age 18 years or older\n* Underwent coronary computed tomography angiography (CCTA) for the diagnosis or assessment of coronary artery disease (CAD) between 2019 and 2024\n* Availability of comparator diagnostic data within 1 month before or after the CCTA, such as: Invasive coronary angiography (ICA), Stress MRI, Alternative CCTA analysis software, Documented clinical events\n\nExclusion Criteria:\n\n\\- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use",{"count":86,"type":20},1000,"The CODEX-1 study is a multicenter retrospective observational study designed to assess the diagnostic performance of a novel software application for coronary artery disease (CAD) evaluation. The application integrates automated stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification, all performed on-site. A total of 1,000 patients who previously underwent coronary computed tomography angiography (CCTA) and diagnostic invasive coronary angiography (ICA) and\u002For other non-invasive imaging will be included. The study compares the diagnostic outputs of the software to current clinical practice and expert adjudication, focusing on CAD-RADS categorization, prediction of the need for percutaneous coronary intervention (PCI), and reduction in unnecessary ICA procedures.",[89,90,91],"Coronary Artery Disease","Atherosclerosis","Myocardial Ischemia","2026-04-20",{"date":94,"type":38},"2026-04-21",{"date":96,"type":38},"2025-07-14",{"date":98,"type":20},"2027-04-30",{"name":44,"class":45},4,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":58,"phases":112,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100545153","phase-1-treatment-of-relapsed-or-refractory-b-cell-lymphoma-with-chimeric-antigen-receptor-car-t-cell-therapy-produced-by-a-new-technology-100545153","NCT06378190","Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology","Multicentre Phase I\u002FIIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission (TranspoCART19) in Patients With Relapsed or Refractory B-cell Lymphoma","TranspoCART19","Inclusion Criteria:\n\n1. Patients diagnosed with relapsed or refractory B-cell lymphoma (Diffuse large B-cell lymphoma, Primary diffuse large B-cell lymphoma of the Central Nervous System (CNS), Mantle cell lymphoma, Follicular lymphoma grades 1, 2 or 3a or Marginal lymphoma, including splenic, nodal and MALT).\n2. Age over 18 years and under 80 years.\n3. Functional status Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Patients with ECOG 2 may be included if motivated by haematological disease (Annex 3).\n4. Adequate bone marrow haematopoietic reserve.\n5. Life expectancy of at least 2 months.\n6. Adequate venous access for lymphapheresis. Absence of contraindications for lymphapheresis.\n7. Signed informed consent (patient or legal guardian).\n\nExclusion Criteria:\n\n1. Patients who, in the opinion of a physician, may benefit from other approved potentially curative therapeutic options, including commercial CAR-Ts.\n2. Treatment with any experimental or non-commercialised substance in the four weeks prior to recruitment, or who are actively participating in another therapeutic clinical trial.\n3. Diagnosis of another neoplasm, past or present. Patients who have been in complete remission for more than 3 years, or with a history of non-melanoma skin cancer or completely resected carcinoma in situ may be included. A current or previous history of clonal T-lymphocytes is also an exclusion criterion.\n4. Early relapse after allogeneic haematopoietic stem cell transplantation (less than 3 months for lymphapheresis, less than 6 months for TranspoCART19 infusion) or patients on active immunosuppressive treatment for graft-versus-recipient disease (corticosteroids or other systemic immunosuppressants).\n5. Active infection requiring systemic medical treatment.\n6. HIV infection.\n7. Concurrent and uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric illnesses that in the opinion of the investigator pose a risk to the patient.\n8. Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBcore antibodies, a hepatitis B virus DNA test will be required, and if the result is positive the patient will be excluded.\n9. Positive serology for hepatitis C virus (HCV), defined as a positive test for anti-HCV antibodies that is confirmed by Recombinant immunoblot assay (RIBA).\n10. Severe organ involvement, defined as cardiac ejection fraction \\\u003C40%; diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40%; calculated glomerular filtration rate \\\u003C30 ml\u002Fmin; baseline O2 saturation \\\u003C92%; bilirubin \\> 2 times upper limit of normal (unless due to Gilbert's syndrome) or transaminases \\> 2.5 upper limit of normal.\n11. Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test at screening.\n12. Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective methods of contraception\\* from the start of the study until the end of the study.\n13. Men who are unable or unwilling to use highly effective methods of contraception\\* from the start of the study until the end of the study.\n14. Need to take glucocorticoids chronically in doses greater than 10 mg\u002Fday of prednisone (or equivalent) or other chronic immunosuppressants.\n15. Previous anti-CD19 CAR-T therapy. Previous treatment with other anti-CD19 strategies is permitted, provided that CD19 expression has been confirmed in the tumour biopsy.\n16. Hypersensitivity to the active substance or to any of the excipients.","80 Years",{"count":111,"type":20},27,[113,114],"PHASE1","PHASE2","The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed\u002Frefractory B-lymphoma. The main questions it aims to answer are:\n\nMaximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.",[117,118],"Refractory B-Cell Lymphoma","B-cell Lymphoma Recurrent","2026-04-13",{"date":121,"type":38},"2026-04-16",{"date":123,"type":38},"2024-03-11",{"date":125,"type":20},"2030-07",{"name":44,"class":45},8,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":58,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100594165","phase-3-dose-escalation-radiotherapy-in-limited-stage-small-cell-lung-cancer-a-phase-iii-randomized-trial-100594165","NCT07015892","Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial","Phase III Randomized Clinical Trial to Evaluate the Efficacy and Safety of Twice-Daily Hyperfractionated Dose-Escalated Thoracic Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (ESCALADOR Study)","ESCALADOR","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of small cell lung cancer (SCLC)\n* Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy\n* Measurable disease according to RECIST 1.1\n* Age ≥18 years\n* ECOG performance status 0-2\n* No prior thoracic radiotherapy\n* Signed informed consent\n* Adequate hematologic function: WBC ≥3.0×10⁹\u002FL, neutrophils ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL\n* Adequate liver and renal function: total bilirubin ≤1.5×ULN, AST\u002FALT ≤1.5×ULN, creatinine normal or CrCl ≥60 mL\u002Fmin\n* Pulmonary function: FEV1 \\>1 L or \\>30% predicted; DLCO \\>30% predicted\n\nExclusion Criteria:\n\n* Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)\n* Presence of malignant cells in pleural or pericardial effusion\n* Serious uncontrolled systemic disorders (e.g., active infection, unstable cardiovascular disease)\n* Medical, psychological, or social conditions that could interfere with compliance\n* Active malignancy other than SCLC (except localized prostate\u002Fbreast cancer or basal cell carcinoma)\n* Refusal or inability to sign informed consent",{"count":137,"type":20},300,[139],"PHASE3","This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). All patients will receive standard chemotherapy with cisplatin and etoposide and will be randomly assigned to one of three radiotherapy regimens.\n\nThe main objective is to determine whether this intensified radiotherapy improves progression-free survival and overall survival. The study will also compare two different dose escalation strategies and assess treatment side effects and patients' quality of life.\n\nThis research may help identify a more effective treatment approach for patients with limited-stage SCLC and could contribute to improving long-term survival in this aggressive type of cancer",[142],"Small Cell Lung Carcinoma",[144,145,146,147],"Radiotherapy","Chemoradiotherapy","Dose-Response Relationship","Radiation","2026-03-25",{"date":150,"type":38},"2026-03-31",{"date":152,"type":38},"2026-03-01",{"date":154,"type":20},"2028-12-31",{"name":44,"class":45},13,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":58,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100585705","phase-2-evaluation-of-allogenic-mesenchymal-stem-cell-msc-injection-therapy-for-refractory-graft-versus-host-disease-gvhd-unresponsive-to-conventional-treatments-100585705","NCT06905834","Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments","A Phase IIB Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments","TER-EYE","Inclusion Criteria:\n\n* Patients over 18 years of age who understand and sign the informed consent form.\n* Diagnosis of severe GVHD (graft versus host disease) according to NIH criteria (revised by Lee SJ in 2017) with ocular involvement in the form of severe SOD (severe ocular disease) in both eyes for more than 3 months, objectively defined as superficial punctate keratitis \\>2 on the Oxford scale (range 0-5) and\u002For the presence of epithelial defect, and subjectively as severe symptoms, \\>33 points on the OSDI questionnaire (0-100).\n* Patients must have previously been treated for at least three months with blood derivatives and\u002For insulin eye drops and topical cyclosporine or tacrolimus (unless any of these treatments were not tolerated and had to be discontinued).\n* Patients must be using ocular lubricants at least 4 times a day and, despite this, still meet the criteria for severe SOD as outlined in point 2.\n* Patients on low doses of topical corticosteroids for maintenance should have a stable dose for at least one month prior to inclusion.\n* The dose and frequency of all topical medications the patient begins the trial with must remain unchanged throughout the duration of the trial, unless otherwise judged by the investigator.\n* The chronic GVHD systemic treatment should be stable regarding the use of systemic immunosuppressors for at least one month prior to patient inclusion or before starting treatment.\n* Negative result in the urine pregnancy test at the baseline visit for women of childbearing age. Subjects must be advised to use contraceptive methods during their participation in the clinical trial and undergo a new pregnancy test at the treatment visit if more than 28 days have passed since the baseline visit.\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease or any condition that, in the medical judgment, could put the patient at risk or affect the interpretation of the results.\n* Uncontrolled systemic GVHD.\n* Active ocular infection.\n* Ocular surgery within the last 3 months.\n* Initiation of topical therapies for SOD indicated in the inclusion criteria less than 3 months prior to inclusion.\n* Start of topical corticosteroid use within 4 weeks prior to inclusion.\n* Cognitive impairments that could interfere with study compliance.\n* Pregnant women or women during the lactation period.",{"count":166,"type":20},30,[114],"This Phase IIB, multicenter, double-blind, randomized, and uncontrolled clinical trial aims to assess the efficacy and safety of subconjunctival injection of Mesenchymal Stem Cells (MSCs) in patients with Graft-versus-Host Disease (GVHD) and severe ocular involvement (DYD-dry eye disease). The primary objective is to evaluate the clinically and statistically significant improvement in the signs and symptoms associated with the disease.\n\nSecondary objectives include:\n\n* Analyzing adverse events related to the subconjunctival injection of MSCs to confirm the safety of this treatment in patients with GVHD ocular involvement.\n* Identifying new biomarkers that can be used to objectively assess the progression of patients with GVHD and severe ocular involvement.\n* Studying the relationship between the expression of ocular surface-specific markers by MSCs and their clinical efficacy, as well as the variation in the expression of these markers in relation to cell preservation methods.\n\nAssessing the quality of life of patients treated with two doses of MSCs using the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire).\n\n\\- Evaluating whether the cell dose impacts clinical improvement.\n\nThe trial includes 30 patients, divided into two groups of 15, and focuses on the assessment of dry eye disease, with the treatment based on MSC administration to improve clinical outcomes and quality of life for the patients.",[170,171],"Dry Eye Disease (DED)","Graft-Versus-Host Disease(GVHD)",[173,174,175],"dry eye disease","Graft-versus-Host Disease","mesenchymal stem cells","NOT_YET_RECRUITING","2026-03-24",{"date":179,"type":38},"2026-03-27",{"date":181,"type":20},"2026-05",{"date":183,"type":20},"2028-06",{"name":44,"class":45},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":194,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":76},"100615659","predictors-of-long-term-evolution-in-long-covid-4-year-follow-up-bioicoper-follow-up-study-100615659","NCT07295483","Predictors of Long-Term Evolution in Long COVID; 4-Year Follow-Up. (BioICOPER Follow-up Study)","To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.","Inclusion Criteria:\n\n* Adults ≥18 years old.\n* Confirmed previous SARS-CoV-2 infection.\n* Diagnosis of long COVID according to WHO criteria.\n* Participation in the baseline BioICOPER study.\n* Signed informed consent for re-evaluation.\n\nExclusion Criteria:\n\n* Acute illness preventing participation.\n* Cognitive or physical impairment limiting data collection.\n* Withdrawal of informed consent.\n* Age \\\u003C 18 years old",{"count":193,"type":20},400,"4 Years","Long COVID (persistent COVID) represents a major global health challenge due to its high prevalence (approximately 7%), significant impact on quality of life, and socioeconomic burden. Despite extensive research, diagnostic tools to objectively identify or predict long COVID evolution are still lacking.\n\nThe BioICOPER Follow-up Study aims to analyze the influence of biomarker evolution on clinical symptomatology (particularly chronic fatigue) and vascular health after four years of follow-up among 400 participants previously included in the original BioICOPER cohort.\n\nAdvanced proteomic analysis, vascular function assessment, and machine-learning-based predictive modeling will be used to identify biomarkers associated with disease progression, stratified by sex. This project will contribute to personalized clinical management of long COVID and improved diagnostic and therapeutic strategies in primary care.",[197],"Persistent COVID Condition",[199,200,201,202,203,204,205],"Post-acute COVID syndrome","Vascular aging","Proteomics","Biomarkers","Machine learning","Persistent COVID","Artificial Intelligence","2026-03-10",{"date":208,"type":38},"2026-03-12",{"date":72,"type":38},{"date":211,"type":20},"2029-06",{"name":44,"class":45},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":58,"phases":222,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100607959","phase-4-comparison-between-standard-and-reduced-doses-of-indocyanine-green-in-fluorescence-cholangiography-during-laparoscopic-cholecystectomy-100607959","NCT07195331","Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.","Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Signed informed consent.\n* Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Pregnancy or lactation.\n* Chronic kidney disease (stage \\>IIIb).\n* ICG allergy.\n* Allergy to other iodinated contrast\n* Functional thyroid disease.\n* Emergency non-deferrable surgery.\n* Open approach.\n* Suspicion of gallbladder cancer.\n* Inability to understand the study.",{"count":221,"type":20},122,[223],"PHASE4","Introduction:\n\nThis protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate.\n\nPhase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat).\n\nObjectives:\n\nPrimary objective:\n\n* To analyze differences between treatment groups (standard dose 2.5 mg \\>3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in:\n* Visualization of extrahepatic biliary structures\n* Degree of visualization\n* Degree of background liver fluorescence interference\n* Perceived utility of the technique\n\nSecondary objectives:\n\n* Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results\n* Intraoperative and postoperative complication rates\n* 30-day mortality\n* Impact on operative time and hospital stay\n* Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elective, early or urgent deferred).\n\nMain inclusion criteria:\n\n* Age ≥18 years\n* Signed informed consent\n* Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis, gallbladder polyps with surgical indication)\n\nMain exclusion criteria:\n\n* Age \\\u003C18 years\n* Pregnancy or lactation\n* Chronic kidney disease (stage \\>IIIb)\n* ICG or iodinated contrast allergy\n* Functional thyroid disease\n* Emergency non-deferrable surgery\n* Open approach\n* Suspicion of gallbladder carcinoma\n* Inability to understand the study Investigational product: Indocyanine green (ICG), intravenous administration\n\nThis multicenter study involves two hospitals in Castilla y León, Spain, and plans to enroll 122 adult patients meeting specific clinical criteria for LC. Participants will be randomized into two treatment arms and will receive ICG accordingly:\n\n* Group 1: 2.5 mg \\>3h before surgery\n* Group 2: 0.25 mg 15-30 min before surgery Fluorescence will be assessed both subjectively by the surgical team and objectively through digital image analysis using specialized software to calculate the bile duct-to-liver fluorescence ratio (RFBH).\n\nEndpoints:\n\n* Rates and degree of biliary structure identification pre- and post-dissection\n* Perceived utility of cholangiography\n* Liver background fluorescence interference\n* Ducts-to-liver fluorescence ratio Duration: 12 months recruitment + 1 month follow-up = total 13 months Countries: Spain Ethics: The study will be conducted in accordance with ICH-GCP, EU Clinical Trials Regulation No 536\u002F2014, and applicable national regulations.\n\nBeyond comparing the diagnostic performance of two dosing strategies, this study seeks to provide evidence supporting a more practical and logistically feasible approach for implementing ICG fluorescence cholangiography in routine surgical practice, without compromising diagnostic accuracy or patient safety.",[226],"Laparoscopic Cholecystectomy Surgery",[228,229,230,231],"laparoscopic cholecystectomy","bile ducts","cholangiography","indocyanine green","2026-03-06",{"date":234,"type":38},"2026-03-09",{"date":236,"type":38},"2026-02-26",{"date":238,"type":20},"2027-01-31",{"name":44,"class":45},2,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":248,"maxAge":4,"enrollmentInfo":249,"targetDuration":250,"studyType":22,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":76},"100619735","urinary-biomarker-based-diagnostic-and-monitoring-system-for-chronic-kidney-disease-and-real-world-effectiveness-of-sglt2-inhibitors-100619735","NCT07348484","Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors","Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin","Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosed with chronic kidney disease (KDIGO stages 2-4)\n* Life expectancy ≥12 months\n* Available clinical and laboratory data in the electronic medical record\n\nExclusion Criteria:\n\n* Current or recent renal replacement therapy or kidney transplantation\n* End-stage renal disease\n* Participation in interventional trials that may affect outcomes\n* Allergy or intolerance to SGLT2i (for exposed cohort)","16 Years",{"count":137,"type":20},"1 Year","This prospective observational study aims to assess the association between real-world use of sodium-glucose co-transporter 2 inhibitors (SGLT2i; e.g., empagliflozin, dapagliflozin) and renal function decline in adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification). The study will also validate a urinary biomarker panel for early diagnosis and monitoring of CKD progression.\n\nNo investigational product is assigned, and medical practice or prescription patterns are not altered.",[253],"Chronic Kidney Disease",[255,256,257],"SGLT2 inhibitors","empagliflozin","urinary biomarker","2026-01-12",{"date":260,"type":38},"2026-01-16",{"date":262,"type":20},"2026-01",{"date":264,"type":20},"2028-03",{"name":44,"class":45},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":58,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100613576","using-advanced-ct-scans-and-blood-markers-to-better-understand-heart-damage-and-recovery-after-a-heart-attack-100613576","NCT07268391","Using Advanced CT Scans and Blood Markers to Better Understand Heart Damage and Recovery After a Heart Attack","SPEctral CT and miRna In Acute Myocardial Infarction for Comprehensive Adverse Remodeling Evaluation","Inclusion Criteria:\n\n* Adults ≥18 years.\n* First STEMI treated with primary PCI.\n* Left ventricular ejection fraction (LVEF) ≤45% during index hospitalization.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Contraindication to iodinated contrast media.\n* Chronic kidney disease with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m².\n* Prior myocardial infarction or known cardiomyopathy.\n* Contraindication to CT or MRI imaging.\n* Life expectancy \\\u003C1 year due to non-cardiac conditions.",{"count":274,"type":20},95,[60],"Acute myocardial infarction with ST-segment elevation (STEMI) remains a leading cause of morbidity and mortality worldwide. Although advances in reperfusion therapy have reduced early mortality, many patients later develop adverse ventricular remodeling (AVR), which increases the risk of heart failure and cardiovascular death. Current imaging methods, such as echocardiography and cardiac magnetic resonance (CMR), provide valuable prognostic information but have limitations in availability, cost, and their ability to predict AVR early and individually.\n\nSpectral computed tomography (CT) is an emerging imaging technique that can characterize myocardial tissue, quantify infarct size, assess microvascular obstruction, and detect complications, with lower contrast and radiation requirements compared to conventional CT. In parallel, circulating microRNAs (miRNAs) have been identified as stable and non-invasive biomarkers that reflect key biological processes in post-infarction remodeling. Several miRNAs are linked to fibrosis, apoptosis, and ventricular remodeling, suggesting their potential to complement imaging findings in risk prediction.\n\nThis study proposes a multicenter, prospective cohort of patients with STEMI and reduced left ventricular function to evaluate whether combining spectral CT tissue characterization with serum miRNA profiling can improve early prediction of AVR. The main objective is to generate and validate a multiparametric prognostic model integrating imaging and molecular biomarkers to identify high-risk patients who may benefit from closer monitoring and tailored therapeutic strategies.",[278],"Acute Myocardial Infarction (AMI)",[280,281,282,283,284],"magnetic resonance","miRNA","myocardial infarction","adverse ventricular remodeling","spectral computed tomography","2025-12-09",{"date":287,"type":38},"2025-12-10",{"date":262,"type":20},{"date":290,"type":20},"2028-12",{"name":44,"class":45},5,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":302,"studyType":22,"phases":4,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":76},"100597887","next-gen-flow-cytometry-to-find-immune-profiles-treatment-response-and-toxicity-markers-in-skin-cancer-patients-treated-with-cemiplimab-100597887","NCT07064330","Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.","Next Generation Flow Cytometry for Global Immunological Profile, Response And Toxicity Biomarker Signatures in Cutaneous Squamous Cell Carcinoma Under CEmiplimab Treatment.","NGF-GRACE","\\- Inclusion criteria At least 18 years old\n\nHepatic function:\n\n1. Total bilirubin ≤1.5x upper limit of normal (ULN) (or ≤3x ULN, if liver metastases).\n2. Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor\n3. Transaminases ≤3x ULN (or ≤5x ULN, if liver metastases)\n4. Alkaline phosphatase (ALP) ≤2.5x ULN (or ≤5x ULN, if liver or bone metastases) Renal function: Serum creatinine ≤2x ULN or estimated creatinine clearance \\>35 mL\u002Fmin (according the method of Cockcroft and Gault) Creatine phosphokinase (CPK) (also known as CK \\[creatine kinase\\]) elevation ≤ grade 2\n\nBone marrow function:\n\na. Hemoglobin ≥9.0 g\u002FdL b. Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL c. Platelet count ≥75 x 109\u002FL Anticipated life expectancy \\>12 weeks\n\n\\- Exclusion criteria:\n\n1. \\- Patient who refuses to participate in the study.\n2. Being unsuitable for cemiplimab treatment\n3. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment.\n4. Untreated brain metastasis(es) that may be considered active.\n\n   a. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period), and there is no evidence of new or enlarging brain metastases, and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of REGN2810cemiplimab.\n5. Immunosuppressive corticosteroid doses (\\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810cemiplimab\n\n   a. Note in clarification: Patients who require brief courses of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded\n6. Active infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV)\n7. History of pneumonitis within the last 5 years\n8. Any anticancer treatment other than radiation therapy (chemotherapy, targeted systemic therapy, imiquimod, photodynamic therapy), investigational or standard of care, within 30 days of the initial administration of REGN2810 cemiplimab or planned to occur during the study period\n9. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments\n10. Patients with allergy or hypersensitivity to REGN2810 cemiplimab or to any of the excipients must be excluded.\n11. Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor)\n12. Breastfeeding\n13. Positive serum pregnancy test (a false positive pregnancy test, if demonstrated by serial measurements and negative ultrasound, will not be exclusionary, upon communication with and approval from the medical monitor)\n14. Receipt of live vaccines (including attenuated) within 30 days of first study treatment\n15. Women of childbearing potential (WOCBP)\\*, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 6 months after the last dose.\n\n    Optional criteria, depending on the therapy being investigated:\n16. Prior treatment with an agent that blocks the PD-1\u002FPD-L1 pathway (If a study is addressing prior unsuccessful treatment with PD-1\u002FPD-L1 inhibitor, it is suggested to exclude patients who had suffered from ≥grade 3 irAE during previous treatment)\n17. Prior treatment with other systemic immune-modulating agents within fewer than 28 days prior to the first dose of REGN2810cemiplimab. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.\n\n    1. Note in clarification: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary",{"count":166,"type":20},"24 Months","Cutaneous squamous cell carcinoma (CSCC) is the second most frequent cancer in humans, it exhibits a high tumor mutational burden and is more common in immunocompromised patients, which aimed to explore the impact of immunotherapy in this cancer. CSCC shows good response to anti-PD1 immunotherapy, and cemiplimab is the first FDA-approved and the only EMA-approved treatment for this tumor. However, 50% of patients won't respond to anti-PD1 and to date there is little evidence on the reasons for such a lack of effectiveness. Also, anti-PD1 immunotherapy is very safe, but some patients will develop adverse events, and anticipating severe adverse events might help in patients' management. The NGF-GRACE project aims to find biomarkers of response and toxicity, both in the blood and the tumor, using advanced technologies. The goal is to move towards more personalized treatments, better select patients, predict side effects, and improve our understanding of the immune system in CSCC.",[305],"Cutaneous Squamous Cell Carcinoma (CSCC)",[307,308,309],"Cemiplimab","Rhapsody Single Cell System","Tumor Microenvironment","2025-09-03",{"date":312,"type":38},"2025-09-10",{"date":314,"type":38},"2025-07-17",{"date":316,"type":20},"2027-06",{"name":44,"class":45},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":100},"100545287","unified-platform-for-a-better-integral-evaluation-of-myelodysplastic-syndromes-in-spain-strategy-for-unraveling-personalized-genomic-medicine-in-public-health-system-umbrella-summa-100545287","NCT06379945","Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA)","UMBRELLA-SUMMA","Inclusion Criteria:\n\n* Patients over 18 years old\n* Patients with a confirmed diagnosis of MDS by cytogenetics and\u002For morphological analysis\n* Patients with complete clinical data\n* Patients who sign the informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients who do not sign the informed consent",{"count":137,"type":20},"Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.\n\nMore concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and\u002For plasma from all prospective MDS patients.\n\nOn the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches.",[328],"Myelodysplastic Syndromes",[330,331,205,332],"Optical Genome Mapping","Next Generation Sequencing","Clonal evolution","2025-04-29",{"date":335,"type":38},"2025-05-02",{"date":337,"type":38},"2024-01-01",{"date":339,"type":20},"2026-12-31",{"name":44,"class":45},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":364,"locationsCount":76},"100545510","novel-flow-cytometry-approaches-to-improve-the-detection-of-tumor-cells-in-ctcl-100545510","NCT06382844","Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL","Design, Development, and Validation of Novel \"Next Generation Flow\" Approaches for Rapid, Specific, Sensitive, and Reproducible Detection of Tumor Cells in Cutaneous T-cell Lymphoma.","Inclusion Criteria:\n\n* Patients with cutaneous T-cell lymphoma\n* Over 18 years old\n* Sign the informed consent\n\nExclusion Criteria:\n\n* Under 18 years old\n* Do not sign the informed consent",{"count":349,"type":20},100,"Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)\u002FSézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF\u002FSS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination\u002Fprocedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and\u002For NGS, performed on cell populations previously sorted by flow cytometry).",[352],"Cutaneous T-Cell Lymphoma",[354,355,356,357,358,359],"Lymphoma","T Cell","Cutaneous","Flow cytometry","Mycosis fungoides","Sézary syndrome",{"date":361,"type":38},"2025-05-01",{"date":337,"type":38},{"date":339,"type":20},{"name":44,"class":45},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":386,"leadSponsor":387,"locationsCount":76},"100549832","study-of-the-hematopoietic-niche-and-the-role-of-inflammation-in-the-pathophysiology-of-cytopenias-after-car-t-cell-therapy-potential-of-therapies-directed-to-repair-the-bone-marrow-microenvironment-100549832","NCT06439173","Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy: Potential of Therapies Directed to Repair the Bone Marrow Microenvironment","Inclusion Criteria:\n\n* Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy\n* Over 18 years old\n* Sign the informed consent\n\nExclusion Criteria:\n\n* Under 18 years old\n* Do not sign the informed consent",{"count":372,"type":20},40,"Immunotherapy with chimeric antigen receptor T-cells (CAR-T) has revolutionized the treatment of oncohematological diseases and its applications in solid tumors and non-neoplastic diseases are advancing. Cytopenias after CAR-T therapy are the most frequent complication in the medium and long term after treatment, they are a cause of morbimortality, and there are no effective therapies available.\n\nThe general objective of the present research project is to analyze, in a series of 40 patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca, the characteristics of the hematopoietic niche and the systemic and bone marrow inflammatory status in patients with prolonged cytopenias after CAR-T cell therapy with respect to those without cytopenias and with respect to the pre-treatment situation (performing quantitative and functional analysis of the stroma by immunohistochemistry, flow cytometry and genomic studies, in addition to functional hematopoietic assays-clonogenic assays, long-term cultures-), and to evaluate both in vitro (by co-culturing with macrophages activated by CAR-T\u002Ftumor cell interaction and assessing cytokines) and in vivo (in an animal model of lymphoma and CRS) the therapeutic potential of therapies aimed at repairing the hematopoietic bone marrow microenvironment, such as the use of allogeneic mesenchymal cells (MSC) from healthy donors and MSC-derived extracellular vesicles (MSC-EV) studying their effects on inflammatory mediators, hematopoiesis and the cytotoxic effect of CAR-T.",[375],"Diffuse Large B Cell Lymphoma",[377,378,379,380,381],"Lymphoma B Cell","CAR-T Therapy","Cytopenia","Hematopoietic Niche","Inflammation","2024-05-31",{"date":384,"type":38},"2024-06-03",{"date":337,"type":38},{"date":339,"type":20},{"name":44,"class":45},""]