[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541097":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":26,"locations":10,"responsibleParty":36,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":52,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MIBC patients who received NAC",null,"Patients with muscle-invasive bladder cancer who received neoadjuvant chemotherapy before radical cystectomy or bladder preservation",[13],"Combination Product: neoadjuvant chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"COMBINATION_PRODUCT","neoadjuvant chemotherapy","platinum-based chemotherapy before radical cystectomy or bladder preservation",[9],[21,24],{"name":22,"affiliation":5,"role":23},"Amal R Ibrahim, Ass.Prof","STUDY_DIRECTOR",{"name":25,"affiliation":5,"role":23},"Hanan G Mostafa, Professor",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Gehad A Abdelrazik, ass.lecturer","CONTACT","01097381211","dr.gehadahmed95@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Hebatullah M Bakri, Lecturer","01007272760","heba_bakri@aun.edu.eg",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Gehad Ahmed Abd El-Razik","Assistant Lecturer","100541097","predicting-response-to-neoadjuvant-chemotherapy-in-muscle-invasive-bladder-cancer-100541097",false,"NCT06325423","Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer","The Impact of Tumor Microenvironment and Clinicopathological Features in Predicting Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Pathologically proven pure urothelial carcinoma, or morphologic variant of urothelial carcinoma.\n* Patients with ≥T2, N0-1, M0, according to American Joint Committee on Cancer (AJCC) TNM Staging System for Bladder Cancer 8th ed., 2017.\n* Patients who received platinum-based neoadjuvant chemotherapy before RC or BP.\n* Available paraffin-embedded TUR specimens for Immunohistochemistry (IHC).\n\nExclusion Criteria:\n\n* Non urothelial carcinoma.\n* Not muscle invasive \\\u003C T2.\n* Metastatic bladder cancer.\n* No available paraffin-embedded TUR specimens for IHC.","ALL","19 Years",{"count":50,"type":51},50,"ESTIMATED","2 Years","OBSERVATIONAL","Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.\n\nThe mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.\n\nThe 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.\n\nTumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.\n\nNETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.\n\nOn the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC.",[56],"Muscle-Invasive Bladder Carcinoma",[58],"MIBC","NOT_YET_RECRUITING","2024-03-22",{"date":62,"type":63},"2024-03-26","ACTUAL",{"date":65,"type":51},"2024-04",{"date":67,"type":51},"2027-06",{"name":5,"class":6}]