RecruitingNot ApplicableNCT07090070

Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors

Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study


Sponsor

University of British Columbia

Enrollment

636 participants

Start Date

Jul 8, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Cohort 1 Intervention group, a procedure called Cohort 2 p53 and severe/CIS margins clear, and others for people with oral epithelial dysplasia (oed) and oral squamous cell carcinoma (scc). The study is currently recruiting participants at 1 location.

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

PROCEDURECohort 1 Intervention group

Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.

PROCEDURECohort 2 severe/CIS margins clear

Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear

PROCEDURECohort 2 p53 and severe/CIS margins clear

Excision of the lesion ensuring final negative p53 and severe/CIS margins

PROCEDURECohort 3 Excision and END

Excision of primary lesion and immediate elective neck dissection

PROCEDURECohort 3 Excision and Close follow up

Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease


Locations(1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

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NCT07090070