Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
University of British Columbia
636 participants
Jul 8, 2026
INTERVENTIONAL
Conditions
Summary
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/CIS excision margins in patients with p53-abnormal HGD will reduce the progression to invasive SCC, compared to clear severe/CIS margins, within 4 years. Finally, it is thought that patients with p53-abnormal cT1N0 and DOI\<4mm receiving an END will have improved disease free and overall survival. This research will elucidate whether or not these hypotheses are correct. Participants in each diagnostic cohort will be assigned to one of two different treatment options, listed below: Cohort 1: A) No intervention, observation only B) Surgical excision with clear margins Cohort 2: A) Surgical excision with clear severe/CIS margins B) Surgical excision with clear severe/CIS and p53 margins Cohort 3: A) Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Excision of primary lesion and immediate elective neck dissection
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
Locations(1)
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NCT07090070