[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520769":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":162,"collaborators":164,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":10,"eligibilityCriteria":174,"healthyVolunteers":170,"sex":175,"minAge":176,"maxAge":10,"enrollmentInfo":177,"targetDuration":10,"studyType":180,"phases":10,"briefSummary":181,"conditions":182,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"This cohort involves all CS-I GCT patients which is defined as GCT in orchiectomy specimen (seminoma and NSGCT), normal conventional staging imaging, and normal\u002Flow stable tumor markers. The current standard of care for management of CS-I disease is either surveillance, RPLND, or systemic therapy. Surveillance is preferred however is largely dependent on clinician discretion. In this cohort miRNA-371 level will be drawn at any timepoint after orchiectomy. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years.",[13],"Other: Clinical Stage I Disease",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","This cohort involves all GCT patients with radiographically enlarged retroperitoneal lymph nodes \\\u003C3 cm (initial CS-I GCT patients with radiographic evidence of retroperitoneal lymph node enlargement and de-novo CS-II patients). In this cohort, miRNA-371 level will be drawn at any timepoint after orchiectomy. Patients with initial CS-I and retroprertioneal relapse\u002F de-novo CS-II disease and normal miRNA-371 levels will undergo reassessment (repeat cross sectional imaging and miRNA level) after 6 weeks. If mass is stable and miRNA-371 level remains normal then patients will continue on surveillance. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years.",[18],"Other: Clinical Stage I with relapse, CSII Disease",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Clinical Stage I Disease","Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or standard surveillance. Surveillance will follow until year 5.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Clinical Stage I with relapse, CSII Disease","Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or reassessment and then surveillance will follow until year 5.",[15],[29],{"name":30,"affiliation":5,"role":31},"Siamak Daneshmand, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Ileana Aldana","CONTACT","323-865-0702","Ileana.Aldana@med.usc.edu",[39,60,77,92,102,122,139],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Alabama at Birmingham Cancer Center","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-86.80249,33.52066,{"lat":51,"lon":50},[54,58],{"name":55,"role":35,"phone":56,"phoneExt":10,"email":57},"Alisha Hitt","205-539-2908","aghitt@uabmc.edu",{"name":59,"role":31,"phone":10,"phoneExt":10,"email":10},"Charles Peyton, MD",{"facility":61,"status":41,"city":62,"state":63,"zip":64,"country":45,"countryCode":46,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Loma Linda University Medical Center","Loma Linda","California","92530",{"type":48,"coordinates":66},[67,68],-117.26115,34.04835,{"lat":68,"lon":67},[71,75],{"name":72,"role":35,"phone":73,"phoneExt":10,"email":74},"Tiffany Sanchez","909-558-7251","TISanchez@llu.edu",{"name":76,"role":31,"phone":10,"phoneExt":10,"email":10},"Alsyouf Muhannad, MD",{"facility":78,"status":41,"city":79,"state":63,"zip":80,"country":45,"countryCode":46,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Los Angeles County-USC Medical Center","Los Angeles","90033",{"type":48,"coordinates":82},[83,84],-118.24368,34.05223,{"lat":84,"lon":83},[87,88,89],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":90,"role":91,"phone":10,"phoneExt":10,"email":10},"Muhannad Alsyouf, MD","SUB_INVESTIGATOR",{"facility":93,"status":41,"city":79,"state":63,"zip":80,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"USC \u002F Norris Comprehensive Cancer Center",{"type":48,"coordinates":95},[83,84],{"lat":84,"lon":83},[98,100,101],{"name":99,"role":35,"phone":36,"phoneExt":10,"email":37},"Ileana Aldana, MD",{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":90,"role":91,"phone":10,"phoneExt":10,"email":10},{"facility":103,"status":41,"city":104,"state":105,"zip":106,"country":45,"countryCode":46,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Emory University Hospital\u002FWinship Cancer Institute","Atlanta","Georgia","30322",{"type":48,"coordinates":108},[109,110],-84.38798,33.749,{"lat":110,"lon":109},[113,117,120],{"name":114,"role":35,"phone":115,"phoneExt":10,"email":116},"Sophie Kim","404-778-4898","sophie.kim@emory.edu",{"name":118,"role":35,"phone":115,"phoneExt":10,"email":119},"Sierra Thomson","sierra.williams@emory.edu",{"name":121,"role":31,"phone":10,"phoneExt":10,"email":10},"Viraj Master, MD",{"facility":123,"status":41,"city":124,"state":125,"zip":126,"country":45,"countryCode":46,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Rutgers Cancer Institute of New Jersey \u002F Jack and Sheryl Morris Cancer Center","New Brunswick","New Jersey","08901",{"type":48,"coordinates":128},[129,130],-74.45182,40.48622,{"lat":130,"lon":129},[133,137],{"name":134,"role":35,"phone":135,"phoneExt":10,"email":136},"Alicia Moore","732-609-1144","aca108@cinj.rutgers.edu",{"name":138,"role":31,"phone":10,"phoneExt":10,"email":10},"Thomas Jang, MA",{"facility":140,"status":41,"city":141,"state":142,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"University Health Network","Toronto","Ontario","M5G 2C4","Canada","CA",{"type":48,"coordinates":147},[148,149],-79.39864,43.70643,{"lat":149,"lon":148},[152,157,160],{"name":153,"role":35,"phone":154,"phoneExt":155,"email":156},"Rida Khan","(416) 946-4501","2282","rida.khan2@uhn.ca",{"name":158,"role":35,"phone":10,"phoneExt":10,"email":159},"Stephen Cox","stephen.cox3@uhn.ca",{"name":161,"role":31,"phone":10,"phoneExt":10,"email":10},"Robert Hamilton, MD",{"type":163,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[165],{"name":166,"class":167},"National Cancer Institute (NCI)","NIH","100520769","magestic-trial-mirna-in-detecting-active-germ-cell-tumors-in-early-suspected-and-metastatic-disease-trial-100520769",false,"NCT06060873","MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial","Phase II Trial of Serum Micro RNA-371 in Detecting Active Germ Cell Tumors in Patients With Suspected Regional Disease - (MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial)","Inclusion Criteria:\n\n* Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)\n* Clinical stage of patient is either:\n\n  * Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA\u002FB pure seminoma\n  * Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA\u002FB NSGCT\n* For subjects with retroperitoneal lymphadenopathy: no lymph node \\>3 cm in greatest dimension with no more than 2 nodes enlarged\n* Axial abdominal\u002Fpelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 3 months of enrollment if stage I patient\n* Axial abdominal\u002Fpelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 8 weeks of enrollment if stage II patient\n* miRNA-371 can be drawn and sent for analysis at time of consent\n* Enrollment within 1 year after orchiectomy for stage I patients\n* Enrollment at any timepoint after orchiectomy for stage II patients\n* Retroperitoneal lymphadenopathy must be within an RPLND template\n* Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT\n* Serum Alpha Feto Protein (AFP) \\\u003C50 ng\u002Fml, β-Human Chorionic Gonadotropin (β-HCG) 25 mIU\u002Fml within 42 days (6 weeks) of enrollment\n* Age ≥ 18 years\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Second primary malignancy\n* Patients receiving any other investigational agent (s)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","MALE","18 Years",{"count":178,"type":179},418,"ESTIMATED","OBSERVATIONAL","This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.",[183],"Malignant Testicular Germ Cell Tumor","2026-08-19",{"date":186,"type":187},"2026-08-20","ACTUAL",{"date":189,"type":187},"2023-06-08",{"date":191,"type":179},"2028-12-08",{"name":5,"class":6},7]