[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Proteocyte Diagnostics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,64],{"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,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100410281","early-prediction-of-oral-cancer-by-s100a7-immunohistochemistry-signature-based-assessment-100410281","NCT04622462","Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment","A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE","Inclusion Criteria:\n\n* Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia\u002Foral squamous cell carcinoma\n\nExclusion Criteria:\n\n* Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy","15 Years","90 Years",{"count":74,"type":19},500,"The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.",[77],"Oral Neoplasm",[25,26,27,28,79,80,31,32,33,81,82,36,37,83,84,85,86,87,88,89,90,91,92,46,93,94,95,96,97,98,99,100],"Oral Epithelial Dysplasia","S100A7 Biomarker","Oral Neoplasia","Oral Epithelial Atypia","Oral Squamous Cell Carcinoma","Oral Cancer","Potentially Premalignant Oral Epithelial Lesion","OPMD","Mild Dysplasia","Moderate Dysplasia","Severe Dysplasia","Low-grade Dysplasia","High-grade Dysplasia","Personalized Medicine","Whole Slide Imaging","Computational Pathology","Digital Pathology","Artificial Intelligence","Machine Learning","OPML","Oral Potentially Malignant Disorder","Oral Potentially Malignant Lesion",{"date":54,"type":55},{"date":103,"type":55},"2015-03-12",{"date":105,"type":19},"2026-12-31",{"name":61,"class":62},3,""]