[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431802":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":82,"collaborators":86,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (no kidney injury)",null,"Patients who receive ICI but no develop kidney injury",[13,14],"Diagnostic Test: Early kidney damage biomarkers","Diagnostic Test: Predisposition to kidney injury biomarkers",{"label":16,"type":10,"description":17,"interventionNames":18},"Case (kidney injury)","Patients who receive ICI and develop kidney injury",[13,14],[20,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Early kidney damage biomarkers","In the urine samples of these patients, a series of biomarkers of early kidney damage and \u002F or predisposition to kidney damage will be measured.",[16,9],[26,27,28,29],"albumin","N-acetyl-beta-D-glucosaminidase (NAG)","Kidney Injury Molecule-1 (KIM-1)","Neutrophil gelatinase-associated lipocalin (NGAL)",{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Predisposition to kidney injury biomarkers","In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.",[16,9],[35,36],"Transferrin","Ganglioside GM2 activator isoform 1 (GM2AP)",[38],{"name":39,"affiliation":40,"role":41},"Ana Isabel Morales Martín, PhD","University of Salamanca","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+34923294400","1862","amorales@usal.es",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Laura Vicente Vicente, PhD","1480","lauravicente@usal.es",[53,70],{"facility":54,"status":55,"city":56,"state":10,"zip":10,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Servicio de Oncología del CAUSA","RECRUITING","Salamanca","Spain","ES",{"type":60,"coordinates":61},"Point",[62,63],-3.67975,40.42972,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":68,"phoneExt":69,"email":10},"Edel del Barco Morillo","+34 923291100","55749",{"facility":71,"status":55,"city":72,"state":10,"zip":10,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Servicio de oncología del Hospital Universitario de Valladolid","Valladolid",{"type":60,"coordinates":74},[75,76],-4.72353,41.65541,{"lat":76,"lon":75},[79],{"name":80,"role":44,"phone":81,"phoneExt":10,"email":10},"Milagros Hijas Villahizán","+34 983420000",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","R. Laura Vicente Vicente","University professor",[87,89,91],{"name":88,"class":6},"Instituto de Investigación Biomédica de Salamanca",{"name":90,"class":6},"Hospital Clínico Universitario de Valladolid",{"name":40,"class":6},"100431802","immune-checkpoint-inhibitors-nephrotoxicity-100431802",false,"NCT04902846","Immune Checkpoint Inhibitors Nephrotoxicity","Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Patients waiting for immunotherapy or combination immunotherapy \u002F platinum compounds\n\nExclusion Criteria:\n\n* Patients who are terminally ill\n* Patients who do not wish to sign the informed consent","ALL","18 Years","100 Years",{"count":103,"type":104},220,"ESTIMATED","OBSERVATIONAL","In recent years, immunotherapy has been postulated as one of the most effective strategy in the fight against cancer. The greatest success in this field has been achieved through the inhibition of molecules involved in the brake of the adaptive immune response. The compounds capable of blocking the action of these molecules constitute the \"immune checkpoint inhibitors\" (ICI). Despite its efficacy, the treatment with ICI causes adverse effects, and in the case of kidney damage, the prognosis has been shown to worsen in cancer patients who develop renal dysfunction. Currently, the diagnosis based on laboratory tests is insufficient to predict the underlying kidney injury and identify the type of damage. The hypothesis proposed that the renal lesion could be subclinical, and therefore the possibility of using new urinary biomarkers could be a useful diagnostic tool that would allow these patients to be managed in a preventive (risk markers) and early way (early markers), and even to elucidate if renal damage is due to this therapy or to other factors (differential diagnostic markers). To develop this hypothesis it is proposed to validate biomarkers in patients treated with ICI by developing a prospective study. The diagnostic products derived from this study will improve the clinical practice of cancer treatment with ICI, and therefore the expectancy and quality of life of patients.",[108,109],"Kidney Injury","Antineoplastics Toxicity",[111,112,113,114,115],"Diagnosis","Nephrotoxicity","Prevention","Oncology","Immune check point inhibitors","2025-02-25",{"date":118,"type":119},"2025-02-26","ACTUAL",{"date":121,"type":119},"2021-05-19",{"date":123,"type":104},"2030-12-30",{"name":84,"class":6},2]