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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (SCC). 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 without surgical intervention will progress to high-grade dysplasia 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\<3mm 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 END if development of nodal disease

Conditions

• Oral Epithelial Dysplasia (OED)
• Oral Squamous Cell Carcinoma (SCC)

Interventions

Type	Name	Description
PROCEDURE	Cohort 1 Intervention group	Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
PROCEDURE	Cohort 2 severe/CIS margins clear	Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
PROCEDURE	Cohort 2 p53 and severe/CIS margins clear	Excision of the lesion ensuring final negative p53 and severe/CIS margins
PROCEDURE	Cohort 3 Excision and END	Excision of primary lesions with 5+mm margins and immediate elective neck dissection
PROCEDURE	Cohort 3 Excision and Close follow up	Excision of primary lesion with 5+mm margins and close follow up with salvage elective neck dissection if development of nodal disease

Timeline

• Start date: 2026-03-12
• Primary completion: 2032-01-01
• Completion: 2032-09-01
• First posted: 2025-07-29
• Last updated: 2026-02-17

Locations

1 site across 1 country: Canada