[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mouth-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mouth-diseases":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"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":18,"type":19},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.",[23],"Mouth Diseases",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"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","RECRUITING","2024-11-05",{"date":54,"type":55},"2024-11-07","ACTUAL",{"date":57,"type":55},"2023-01-01",{"date":59,"type":19},"2024-12",{"name":61,"class":62},"Proteocyte Diagnostics Inc.","INDUSTRY",5]