[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineoplastics-toxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineoplastics-toxicity":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,84],{"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":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100530181","phase-4-the-stop-med-ctrcd-trial-100530181",false,"NCT06183437","The STOP-MED CTRCD Trial","A Multi-Centre Non-Inferiority Randomized Controlled Trial of STOPping Cardiac MEDications in Patients With Normalized Cancer Therapy Related Cardiac Dysfunction: The STOP-MED CTRCD Trial","STOP-MED CTRCD","Inclusion Criteria:\n\n* Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD.\n* Prior cancer therapy with anthracyclines and\u002F or HER2-targeted therapy.\n* Prior asymptomatic, moderate to severe CTRCD, defined using the ESC\u002FICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \\\u003C10% drop to 40-49.9% with a reduction in GLS by \\>15% or new abnormal Troponin I\u002FT or NT-proBNP or SEVERE: new LVEF reduction to \\\u003C40% from normal baseline LVEF), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.\n* Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥55% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.\n* Reference ranges for NT-proBNP and BNP by age and sex:\n\n\\\u003C30 years: Female: NT-proBNP ≤196 pg\u002Fml, BNP ≤55 pg\u002Fml Male: NT-proBNP ≤104 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n30-39 years: Female: NT-proBNP ≤209 pg\u002Fml, BNP ≤59 pg\u002Fml Male: NT-proBNP ≤102 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n40-49 years: Female: NT-proBNP ≤233 pg\u002Fml, BNP ≤65 pg\u002Fml Male: NT-proBNP ≤137 pg\u002Fml, BNP ≤38 pg\u002Fml\n\n50-59 years: Female: NT-proBNP ≤299 pg\u002Fml, BNP ≤84 pg\u002Fml Male: NT-proBNP ≤195 pg\u002Fml, BNP ≤55 pg\u002Fml\n\n60-69 years: Female: NT-proBNP ≤399 pg\u002Fml, BNP ≤112 pg\u002Fml Male: NT-proBNP ≤333 pg\u002Fml, BNP ≤93 pg\u002Fml\n\n70-79 years: Female: NT-proBNP ≤743 pg\u002Fml, BNP ≤208 pg\u002Fml Male: NT-proBNP ≤763 pg\u002Fml, BNP ≤214 pg\u002Fml\n\n≥80 years: Female: NT-proBNP ≤2,704 pg\u002Fml, BNP ≤757 pg\u002Fml Male: NT-proBNP ≤6,792 pg\u002Fml, BNP ≤1,902 pg\u002Fml\n\n* Confirmation of LVEF ≥55% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF\u002Fvolumes are not normal). This is included given that the primary outcome includes the use of CMR LVEF.\n\nExclusion Criteria:\n\n* Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular arrythmias, other (note: participants with hypertension will be switched to other guideline-based antihypertensive therapy).\n* Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).\n* Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.\n* Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.\n* Life expectancy \\\u003C1 year or metastatic disease.\n* Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)).\n* Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.","ALL","18 Years",{"count":20,"type":21},335,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \\>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology.\n\nTo address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.",[27,28,29,30,31],"Heart Failure","Cardiotoxicity","Cardiac Toxicity","Antineoplastics Toxicity","Cancer",[33],"cancer therapy related cardiac dysfunction","RECRUITING","2026-03-25",{"date":37,"type":38},"2026-03-30","ACTUAL",{"date":40,"type":38},"2024-03-04",{"date":42,"type":21},"2031-12",{"name":44,"class":45},"Dinesh Thavendiranathan","OTHER",14,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":71,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100534368","phase-2-stage-ii-iiia-urothelial-cancer-randomizing-pre-operative-nivolumab-with-or-without-relatlimab-100534368","NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n* Pregnant and lactating female patients.\n* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.",{"count":56,"type":21},90,[58],"PHASE2","This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[61,62,63,64,65,66,67,68,69,70,30],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Urinary Bladder Diseases","Male Urogenital Diseases","Urinary Bladder Neoplasm",[72,73],"Nivolumab","Relatlimab","2025-09-01",{"date":76,"type":38},"2025-09-03",{"date":78,"type":38},"2024-02-19",{"date":80,"type":21},"2028-08-01",{"name":82,"class":45},"The Netherlands Cancer Institute",9,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100431802","immune-checkpoint-inhibitors-nephrotoxicity-100431802","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","100 Years",{"count":93,"type":21},220,"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.",[97,30],"Kidney Injury",[99,100,101,102,103],"Diagnosis","Nephrotoxicity","Prevention","Oncology","Immune check point inhibitors","2025-02-25",{"date":106,"type":38},"2025-02-26",{"date":108,"type":38},"2021-05-19",{"date":110,"type":21},"2030-12-30",{"name":112,"class":45},"R. Laura Vicente Vicente",2]