[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07514143":3,"trial-entities:NCT07514143":90,"trial-summary:NCT07514143":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":50,"locations":53,"central_contacts":82,"overall_officials":87,"references":88,"see_also_links":89},"NCT07514143","Nucleix","Bladder EpiCheck Product Development Study","Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies","RECRUITING","2026-12","2026-04","2026-04-07","2025-09-15","Nucleix Ltd.","INDUSTRY",false,"This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance.\n\nThis is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.",null,[19,20],"Suspicion of Bladder Cancer","NMIBC Surveillance",[22,23],"EpiCheck","Bladder cancer","OBSERVATIONAL",[],{"count":27,"type":28},1000,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Bladder EpiCheck","Methylation biomarker urine test",[35,36,37],"Subjects planned to undergo TURBT due to suspected or detected bladder tumor","Subjects planned to undergo cystoscopy for NMIBC surveillance","Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor",[39],{"measure":40,"description":41,"timeFrame":42},"The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.","The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.","1 year",[],"ALL","22 Years",{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria:\n\n1. Age 22 or older\n2. Willing and able to sign the informed consent form\n3. Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:\n\n3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance\n\nExclusion Criteria:\n\n1. Patients with known or history of muscle invasive bladder cancer (MIBC)\n2. Treatment of prostate cancer or RCC in the past 2 years\n3. Patients previously enrolled into this study within the prior 60 days",[51,52],"ADULT","OLDER_ADULT",[54,69],{"facility":55,"status":8,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":66},"Om Research LLC","San Diego","California","92103","United States",[61],{"name":62,"role":63,"phone":64,"email":65},"Gavriushina","CONTACT","858.429.7050","agavriushina@omclinicaltrials.com",{"lat":67,"lon":68},32.71571,-117.16472,{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":59,"contacts":74,"geoPoint":79},"Chesapeake Urology Research Associates","Towson","Maryland","21204",[75],{"name":76,"role":63,"phone":77,"email":78},"Phelps","410-205-8590","stephanie.phelps@chesuro.com",{"lat":80,"lon":81},39.4015,-76.60191,[83],{"name":84,"role":63,"phone":85,"email":86},"Limor Klein, PhD","+972-8-9161616","limor.k@nucleix.com",[],[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Bladder Carcinoma",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study planning to enroll 1000 participants. It is not testing a treatment, but rather collecting information to develop a diagnostic test.","completed","Bladder EpiCheck Product Development Study for Bladder Cancer","This study is developing a new diagnostic test called Bladder EpiCheck. This test uses a urine sample to help detect bladder cancer or monitor for its return in people who have had it before. We are looking for 1000 participants aged 22 or older who are suspected of having bladder cancer or are undergoing surveillance for non-muscle invasive bladder cancer (NMIBC). The main goal is to collect urine samples to help improve the Bladder EpiCheck test. This is an observational study, meaning you won't receive a new treatment, but your samples will help develop a new diagnostic tool.","The primary objective is measured at 1 year, but the record does not specify if participants have follow-up visits after the initial single visit.",98,"You would have a single visit where you sign a consent form and provide a urine sample. Information about your demographics and any pathology results will also be collected.","Not stated in the trial record.",[32],"v2"]