[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504857":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":96,"collaborators":98,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":10,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":10,"enrollmentInfo":115,"targetDuration":10,"studyType":118,"phases":10,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Proteocyte Diagnostics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OPMDs that progressed to OSCC",null,"No dysplasia, mild, moderate, severe dysplasia, CIS",[13],"Other: STRATICYTE™ Test",{"label":15,"type":10,"description":11,"interventionNames":16},"OPMDs that did not progress to OSCC",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"OTHER","STRATICYTE™ Test","Assessment for risk of progression to oral cancer",[15,9],[24],"S100A7 Immunohistochemistry Signature-based Test",[26],{"name":27,"affiliation":28,"role":29},"Simon W Young, DDS, MD, PhD","UTHealthHouston","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Jody Filkowski, BSc, MSc, PhD","CONTACT","1-825-305-0749","Jody.Filkowski@medlior.com",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"Jason TK Hwang, HBSc, MSc, PhD","1-647-255-1370","jhwang@proteocyte.com",[41,55,65,76,90],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":10},"The University of Alabama at Birmingham","COMPLETED","Birmingham","Alabama","35233","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.80249,33.52066,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"Loma Linda University","Loma Linda","California","92350",{"type":50,"coordinates":61},[62,63],-117.26115,34.04835,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":47,"countryCode":48,"cosmosGeoPoint":71,"geoPoint":75,"contacts":10},"Minnesota Oral and Facial Surgery","WITHDRAWN","Minneapolis","Minnesota","55415",{"type":50,"coordinates":72},[73,74],-93.26384,44.97997,{"lat":74,"lon":73},{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":47,"countryCode":48,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"MD Anderson Cancer Cetner","RECRUITING","Houston","Texas","44907",{"type":50,"coordinates":83},[84,85],-95.36327,29.76328,{"lat":85,"lon":84},[88],{"name":89,"role":33,"phone":10,"phoneExt":10,"email":10},"Andrew G Sikora, MD, PhD",{"facility":91,"status":43,"city":79,"state":80,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":95,"contacts":10},"UTHealth Houston School of Dentistry","77054",{"type":50,"coordinates":94},[84,85],{"lat":85,"lon":84},{"type":97,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[99,101,102,105],{"name":100,"class":19},"The University of Texas Health Science Center, Houston",{"name":56,"class":19},{"name":103,"class":104},"Minnesota Oral & Facial Surgery","UNKNOWN",{"name":106,"class":19},"University of Alabama at Birmingham","100504857","evaluation-of-oral-potentially-malignant-disorders-opmds-with-straticyte-100504857",false,"NCT05853783","Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™","Inclusion Criteria:\n\n* From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system)\n* Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:\n* No histological evidence of cancer with clinical follow-up data for a period of at least five years; or\n* OSCC development (histologic or documented evidence of invasive cancer).\n* Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.\n\nExclusion Criteria:\n\n* Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients.\n* Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.","ALL","18 Years",{"count":116,"type":117},180,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.",[121],"Mouth Diseases",[123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148],"Leukoplakia","Erythroplakia","Erythroleukoplakia","Lesion","Oral epithelial dysplasia","S100A7 biomarker","S100A7 Immunohistochemistry Signature-based","Early Diagnosis","STRATICYTE","Oral neoplasia","Oral epithelial atypia","Hyperplasia","Hyperkeratosis","Potentially premalignant oral epithelial lesion","Oral potentially malignant disorders","Mild dysplasia","Moderate dysplasia","Severe dysplasia","Low-grade dyspalsia","High-grade dysplasia","Personalized medicine","Predictive Assay","Whole slide imaging","Computational pathology","Digital pathology","Oral potentially malignant lesion","2024-11-05",{"date":151,"type":152},"2024-11-07","ACTUAL",{"date":154,"type":152},"2023-01-01",{"date":156,"type":117},"2024-12",{"name":5,"class":6},5]