[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-epithelial-dysplasia-oed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-epithelial-dysplasia-oed":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},636,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"Oral Epithelial Dysplasia (OED)","Oral Squamous Cell Carcinoma (SCC)",[30,31,32],"p53 mutant","SCC","oral epithelial dysplasia","NOT_YET_RECRUITING","2026-05-29",{"date":36,"type":37},"2026-06-03","ACTUAL",{"date":39,"type":21},"2026-06-01",{"date":41,"type":21},"2032-09",{"name":43,"class":44},"University of British Columbia","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100640938","phase-1-can1012-in-pre-malignant-oral-dysplasia-100640938","NCT07620496","CAN1012 in Pre-malignant Oral Dysplasia","A Phase I\u002FIb Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia","Inclusion Criteria:\n\n1. Clinically-identified oral epithelial dysplasia (OED)\n2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n4. Laboratory values within 72 hours of Day 0:\n\n   1. WBC ≥ 2.0 K\u002FµL, ANC ≥ 1.0 K\u002FµL\n   2. Hgb ≥ 10 g\u002FdL\n   3. Platelets ≥ 100,000 K\u002FµL\n   4. Creatinine Clearance (using Cockcroft-Gault)\n   5. AST\u002FALT ≤ 2.5 x ULN\n   6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL)\n   7. Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)\n5. Patients and their partners who are capable of conceiving must agree to use effective methods of during the course of treatment and for 165 days after last dose of CAN1012.\n\nExclusion Criteria:\n\n1. Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.\n2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.\n3. Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.\n4. History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism\u002F hyperthyroidism are not exclusionary.\n5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).\n6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.\n7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.\n8. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \\> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.\n9. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.",{"count":54,"type":21},36,[56],"PHASE1","The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.",[27],"2026-05-27",{"date":61,"type":37},"2026-06-02",{"date":63,"type":21},"2026-07-01",{"date":65,"type":21},"2033-07",{"name":67,"class":44},"Providence Health & Services"]