[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07645391":3,"trial-entities:NCT07645391":89,"trial-summary:NCT07645391":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":14,"phases":20,"enrollment_info":21,"interventions":24,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":42,"eligibility_criteria":43,"std_ages":60,"locations":63,"central_contacts":81,"overall_officials":84,"references":87,"see_also_links":88},"NCT07645391","HUM00117711","Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer","RECRUITING","2030-01","2026-06","2026-06-12","2017-01-01","University of Michigan Rogel Cancer Center","OTHER",null,"This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.",[17],"Prostate Carcinoma",[],"OBSERVATIONAL",[],{"count":22,"type":23},200,"ESTIMATED",[25],{"type":13,"name":26,"description":27,"armGroupLabels":28,"otherNames":30},"Non-Interventional Study","Non-interventional study",[29],"Observational",[31,32],"Non-Interventional Observational Study","Noninterventional (Observational) Study",[34],{"measure":35,"description":36,"timeFrame":37},"Predictors of any HG PCa","Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables. Will estimate the prevalence and incidence. Will fit two statistical models with cross-validation to evaluate the performance characteristics (Brier score, area under curve, sensitivity, specificity, positive and negative predictive values) of SelectMDx in predicting i) HG PCa and ii) any PCa.","At 5-years follow up",[],"MALE","35 Years","70 Years",false,{"inclusion":44,"exclusion":54,"raw_text":59},[45,46,47,48,49,50,51,52,53],"\\* Age 35-70 years","Capable of providing informed consent","Prognosis of \\> 5 years if affected by another cancer","Patients need one to meet at least one of the following high genetic risk categories:","Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53","Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13","Obligate carriers of the above mutations (e.g. their sisters\u002Fdaughters have known mutations)","Men with any family history of above mutation","Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50",[55,56,57,58],"\\* Anuria","Prior diagnosis or treatment for PCa","Failure to provide informed consent","Life expectancy \\\u003C 5 years","Inclusion Criteria:\n\n* \\* Age 35-70 years\n\n  * Capable of providing informed consent\n  * Prognosis of \\> 5 years if affected by another cancer\n  * Patients need one to meet at least one of the following high genetic risk categories:\n\n    * Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53\n    * Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13\n    * Obligate carriers of the above mutations (e.g. their sisters\u002Fdaughters have known mutations)\n    * Men with any family history of above mutation\n    * Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50\n\nExclusion Criteria:\n\n* \\* Anuria\n\n  * Prior diagnosis or treatment for PCa\n  * Failure to provide informed consent\n  * Life expectancy \\\u003C 5 years",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":12,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":78},"Ann Arbor","Michigan","48109","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Cancer AnswerLine","CONTACT","800-865-1125","CancerAnswerLine@med.umich.edu",{"name":76,"role":77},"Todd M. Morgan, MD","PRINCIPAL_INVESTIGATOR",{"lat":79,"lon":80},42.27756,-83.74088,[82],{"name":71,"role":72,"phone":83,"email":74},"1-800-865-1125",[85],{"name":86,"affiliation":12,"role":77},"Todd M Morgan, MD",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[17],[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110],"ABRAXAS1 wt Allele","ATR Gene","BRCA1 Gene","BRCA2 Gene","BRIP1 Gene","DNA Mismatch Repair Protein Mlh1","Double-Strand Break Repair Protein MRE11","EPCAM Gene","GEN1 Gene","HOXB13 Gene","MSH2 Gene","MSH6 Gene","Nibrin","Partner and Localizer of BRCA2","PMS2 Gene","RAD51C Gene","RAD51D Gene","Serine\u002FThreonine-Protein Kinase Chk2","TP53 Gene",{"nct_id":4,"found":42,"summary":14,"prompt_version":14}]