[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504857":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":38,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":117,"collaborators":119,"id":128,"slug":23,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":23,"eligibilityCriteria":132,"healthyVolunteers":129,"sex":133,"minAge":134,"maxAge":23,"enrollmentInfo":135,"targetDuration":23,"studyType":138,"phases":23,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":99,"whyStopped":23,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Proteocyte Diagnostics Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Sensitivity and Specificity","Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy","5 years",{"measure":14,"description":15,"timeFrame":12},"Survival analysis","Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients\u002Fbiopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.",[17,20],{"measure":18,"description":19,"timeFrame":12},"AUC","Area under the receiver operator curve",{"measure":21,"description":22,"timeFrame":12},"C-index (Harrell's)","From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","RETROSPECTIVE","The study objectives are to:\n\n1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion\u002Fexclusion criteria.\n2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.\n3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.","The target population are patients presenting with an OPMD who have received a biopsy of their lesion. The study sample will be composed of patients with previously biopsied OPMDs from contracted clinics.",[30,35],{"label":31,"type":23,"description":32,"interventionNames":33},"OPMDs that progressed to OSCC","No dysplasia, mild, moderate, severe dysplasia, CIS",[34],"Other: STRATICYTE™ Test",{"label":36,"type":23,"description":32,"interventionNames":37},"OPMDs that did not progress to OSCC",[34],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"OTHER","STRATICYTE™ Test","Assessment for risk of progression to oral cancer",[36,31],[45],"S100A7 Immunohistochemistry Signature-based Test",[47],{"name":48,"affiliation":49,"role":50},"Simon W Young, DDS, MD, PhD","UTHealthHouston","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":23,"email":56},"Jody Filkowski, BSc, MSc, PhD","CONTACT","1-825-305-0749","Jody.Filkowski@medlior.com",{"name":58,"role":54,"phone":59,"phoneExt":23,"email":60},"Jason TK Hwang, HBSc, MSc, PhD","1-647-255-1370","jhwang@proteocyte.com",[62,76,86,97,111],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":23},"The University of Alabama at Birmingham","COMPLETED","Birmingham","Alabama","35233","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-86.80249,33.52066,{"lat":74,"lon":73},{"facility":77,"status":64,"city":78,"state":79,"zip":80,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":85,"contacts":23},"Loma Linda University","Loma Linda","California","92350",{"type":71,"coordinates":82},[83,84],-117.26115,34.04835,{"lat":84,"lon":83},{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":68,"countryCode":69,"cosmosGeoPoint":92,"geoPoint":96,"contacts":23},"Minnesota Oral and Facial Surgery","WITHDRAWN","Minneapolis","Minnesota","55415",{"type":71,"coordinates":93},[94,95],-93.26384,44.97997,{"lat":95,"lon":94},{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":68,"countryCode":69,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"MD Anderson Cancer Cetner","RECRUITING","Houston","Texas","44907",{"type":71,"coordinates":104},[105,106],-95.36327,29.76328,{"lat":106,"lon":105},[109],{"name":110,"role":54,"phone":23,"phoneExt":23,"email":23},"Andrew G Sikora, MD, PhD",{"facility":112,"status":64,"city":100,"state":101,"zip":113,"country":68,"countryCode":69,"cosmosGeoPoint":114,"geoPoint":116,"contacts":23},"UTHealth Houston School of Dentistry","77054",{"type":71,"coordinates":115},[105,106],{"lat":106,"lon":105},{"type":118,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[120,122,123,126],{"name":121,"class":40},"The University of Texas Health Science Center, Houston",{"name":77,"class":40},{"name":124,"class":125},"Minnesota Oral & Facial Surgery","UNKNOWN",{"name":127,"class":40},"University of Alabama at Birmingham","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":136,"type":137},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.",[141],"Mouth Diseases",[143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168],"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":171,"type":172},"2024-11-07","ACTUAL",{"date":174,"type":172},"2023-01-01",{"date":176,"type":137},"2024-12",{"name":5,"class":6},5]