[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640466","impact-of-genetic-variants-on-the-toxicity-of-antibody-drug-conjugates-in-locally-advanced-or-metastatic-breast-cancer-the-role-of-the-ugt1a1-gene-as-a-predictive-biomarker-of-therapeutic-response-100640466",false,"NCT07582887","Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients diagnosed with breast cancer starting or undergoing treatment with Sacituzumab Govitecan, Trastuzumab Deruxtecan, or Datopotamab Deruxtecan.\n* Provision of signed informed consent for the genetic study.\n\nExclusion Criteria:\n\n* Patients who are ultimately not treated with the specified Antibody-Drug Conjugates.\n* Refusal to provide informed consent for genetic analysis.","ALL","18 Years",{"count":18,"type":19},70,"ESTIMATED","2 Years","OBSERVATIONAL","The metabolism of anticancer drugs is influenced by genetic variants that affect their bioavailability and toxicity. In the case of antibody-drug conjugates (ADCs), such as sacituzumab-govitecan (SG), trastuzumab-deruxtecan (T-DXd), and datopotamab-deruxtecan (Dato-DXd), the enzyme UDP-glucuronosyltransferase 1A1 (UGT1A1) plays a central role in the glucuronidation and elimination of their cytotoxic components. In particular, the metabolism of SN-38, the active metabolite of irinotecan and SG, is highly influenced by variants in UGT1A1, leading to drug accumulation and the development of severe toxicities. Patients with variants such as UGT1A1\\*28 (rs3064744) and UGT1A1\\*6 (rs4148323) exhibit reduced enzyme activity, increasing the risk of neutropenia and severe diarrhea.\n\nThe relevance of UGT1A1 is not limited to sacituzumab-govitecan; its role in the elimination of camptothecin derivatives suggests it could also impact the toxicity of trastuzumab-deruxtecan and datopotamab-deruxtecan, which contain deruxtecan, a cytotoxic agent 10 times more potent than irinotecan. Despite strong evidence linking the UGT1A1 genotype to irinotecan toxicity, there are currently no established pharmacogenetic recommendations for antidiuretic peptides (ADCs) in metastatic breast cancer.",[24,25,26,27],"Breast Cancer","Metastatic Breast Cancer","Drug-Related Side Effects and Adverse Reactions","Pharmacogenetic Variant",[29,30,31,32,24,33,34,35],"UGT1A1","Genetic Variants","Toxicity","polymorphism","Sacituzumab Govitecan","Trastuzumab Deruxtecan","Datopotamab Deruxtecan","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-13","ACTUAL",{"date":42,"type":40},"2025-07-15",{"date":44,"type":19},"2027-03-31",{"name":46,"class":47},"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":48},"100580180","high-intensity-interval-training-in-the-treatment-of-familial-hypercholesterolemia-uppa-fh-100580180","NCT06833944","High Intensity Interval Training in the Treatment of Familial Hypercholesterolemia (UPPA-FH)","Unraveling the Potential of Physical Activity in the Treatment of Familial Hypercholesterolemia: Impact of Exercise on Cardiorespiratory Fitness, Atherosclerosis Progression, and Underlying Mechanisms","UPPA-FH","Inclusion criteria:\n\n* Individuals with a diagnosis of genetic FH.\n* \\> 18 years old.\n* Minimum follow-up of 1 year in the Vascular Risk Clinic of the Virgen de las Nieves University Hospital (HUVN).\n* Clinical and treatment stability.\n* Non-pathological angio-TAC of coronary arteries in the 5 years prior to the study (for participants \\>45 years old).\n\nExclusion criteria:\n\n* Inability to read, understand and sign the informed consent.\n* Contraindications to exercise.\n* History of clinical CVD (ischemic heart disease, stroke, and\u002For peripheral arterial disease).",{"count":58,"type":19},75,"INTERVENTIONAL",[61],"NA","This study has one main objective:\n\na) To assess the impact of two different supervised exercise interventions on cardiorespiratory fitness and markers of subclinical atherosclerosis in patients with Familiar Hipercolesterolemia (FH), and to unravel the underlying mechanisms behind these effects.\n\nThe starting hypothesis of the UPPA-FH project anticipates that both exercise interventions will produce a large increase in cardiorespiratory fitness and will improve significant markers of atherosclerosis in patients with FH, with high-intensity interval training program (HIIT) being more efficient than the moderate-intensity continuous training (MICT) modality. The main effects will be mediated by a significant change in the metabolomic signature of the participants. In addition, higher physical activity will be associated with more favorable markers of atherosclerosis progression, as shown through blood and image technique",[64],"Familiar Hypercholesterolemia",[66,67,68,69,70,71],"Inflamation markers","Cardiovascular risk","Physical fitness","Exercise","Cardiovascular disease","LDL cholesterol","NOT_YET_RECRUITING","2025-02-13",{"date":75,"type":40},"2025-02-19",{"date":77,"type":19},"2025-02-15",{"date":79,"type":19},"2026-07-31",{"name":46,"class":47},""]