[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599867":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":12,"centralContacts":59,"locations":70,"responsibleParty":86,"collaborators":12,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":12,"enrollmentInfo":99,"targetDuration":12,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":113,"whyStopped":12,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,13,19,25,30,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: p53 mutant mild\u002Fmoderate dysplasia observational group","NO_INTERVENTION","Observation only",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Cohort 1: p53 mutant mild\u002Fmoderate dysplasia excision group","EXPERIMENTAL","Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins",[18],"Procedure: Cohort 1 Intervention group",{"label":20,"type":21,"description":22,"interventionNames":23},"Cohort 2: p53 mutant Severe\u002FCIS dysplasia clear severe\u002FCIS margin group","ACTIVE_COMPARATOR","Clear margin excision of the lesion under local anesthetic, with re-excision until severe\u002FCIS margins are clear",[24],"Procedure: Cohort 2 severe\u002FCIS margins clear",{"label":26,"type":15,"description":27,"interventionNames":28},"Cohort 2: p53 mutant Severe\u002FCIS dysplasia negative p53 and severe\u002FCIS margin group","Excision of the lesion ensuring final negative p53 and severe\u002FCIS margins",[29],"Procedure: Cohort 2 p53 and severe\u002FCIS margins clear",{"label":31,"type":21,"description":32,"interventionNames":33},"Cohort 3: p53 mutant T1 SCC (DOI \u003C4mm) excision and END group","Excision of primary lesion and immediate elective neck dissection (END)",[34],"Procedure: Cohort 3 Excision and END",{"label":36,"type":15,"description":37,"interventionNames":38},"Cohort 3: p53 mutant T1 SCC (DOI \u003C4mm) excision and follow up group","Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease",[39],"Procedure: Cohort 3 Excision and Close follow up",[41,46,49,52,56],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":12},"PROCEDURE","Cohort 1 Intervention group","Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.",[14],{"type":42,"name":47,"description":22,"armGroupLabels":48,"otherNames":12},"Cohort 2 severe\u002FCIS margins clear",[20],{"type":42,"name":50,"description":27,"armGroupLabels":51,"otherNames":12},"Cohort 2 p53 and severe\u002FCIS margins clear",[26],{"type":42,"name":53,"description":54,"armGroupLabels":55,"otherNames":12},"Cohort 3 Excision and END","Excision of primary lesion and immediate elective neck dissection",[31],{"type":42,"name":57,"description":37,"armGroupLabels":58,"otherNames":12},"Cohort 3 Excision and Close follow up",[36],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":12,"email":64},"Eitan Prisman","CONTACT","6048754126","prisman.eitan@vch.ca",{"name":66,"role":62,"phone":67,"phoneExt":68,"email":69},"Tayo Steininger","6048754111","22935","tayo.steininger@vch.ca",[71],{"facility":72,"status":12,"city":73,"state":74,"zip":12,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Vancouver General Hospital","Vancouver","British Columbia","Canada","CA",{"type":78,"coordinates":79},"Point",[80,81],-123.11934,49.24966,{"lat":81,"lon":80},[84],{"name":61,"role":62,"phone":63,"phoneExt":12,"email":85},"eitan.prisman@ubc.ca",{"type":87,"investigatorFullName":61,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100599867","evaluating-treatment-strategies-for-p53-mutant-oral-cancer-and-oral-cancer-precursors-100599867",false,"NCT07090070","Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors","Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study","p53 RCT","Inclusion Criteria:\n\n* Adults age 18 or over\n* No history of head and neck radiation\n* p53-abnormal IHC patterns (surrogate marker for TP53 mutation)\n\nCohort 1:\n\n* Biopsy-confirmed mild\u002Fmoderate dysplasia\n\nCohort 2:\n\n* Biopsy-confirmed severe dysplasia or CIS\n\nCohort 3:\n\n* T1 SCC with depth of Invasion (DOI) \\\u003C4mm\n* Clinically and radiologically node-negative (confirmed by contrast-enhanced CT)\n\nExclusion Criteria:\n\n* Immunocompromised status\n* Lesions greater than 3 cm\n* Presence of Proliferative Verrucous Leukoplakia\n\nCohort 1:\n\n* Had prior treatment for oral premalignant lesions\n\nCohort 2:\n\n* Presence of invasive SCC on initial biopsy\n\nCohort 3:\n\n* Positive nodes on contrast-enhanced CT\n* DOI \\>= 4mm","ALL","18 Years",{"count":100,"type":101},636,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this clinical trial is to optimize treatment strategies for patients with p53-mutant oral epithelial dysplasia (OED) and early-stage oral squamous cell carcinoma (OSCC). The main question it aims to answer is what the most optimal treatment is at each diagnostic stage. It is hypothesized that lesions with p53-abnormal low-grade dysplasia (LGD) without surgical intervention will progress to high-grade dysplasia (HGD) or SCC in 4 years. It is also predicted that a clear p53 and severe\u002FCIS excision margins in patients with p53-abnormal HGD will reduce the progression to invasive SCC, compared to clear severe\u002FCIS margins, within 4 years. Finally, it is thought that patients with p53-abnormal cT1N0 and DOI\\\u003C4mm receiving an END will have improved disease free and overall survival. This research will elucidate whether or not these hypotheses are correct.\n\nParticipants in each diagnostic cohort will be assigned to one of two different treatment options, listed below:\n\nCohort 1:\n\nA) No intervention, observation only B) Surgical excision with clear margins\n\nCohort 2:\n\nA) Surgical excision with clear severe\u002FCIS margins B) Surgical excision with clear severe\u002FCIS and p53 margins\n\nCohort 3:\n\nA) Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease",[107,108],"Oral Epithelial Dysplasia (OED)","Oral Squamous Cell Carcinoma (SCC)",[110,111,112],"p53 mutant","SCC","oral epithelial dysplasia","NOT_YET_RECRUITING","2026-05-29",{"date":116,"type":117},"2026-06-03","ACTUAL",{"date":119,"type":101},"2026-06-01",{"date":121,"type":101},"2032-09",{"name":5,"class":6},1]