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

Starting soon · Not applicable

Conditions studied: Oral Epithelial Dysplasia (OED), Oral Squamous Cell Carcinoma (SCC)

In brief

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

Key facts

Study ID

NCT07090070

Run by

University of British Columbia

People needed

636

Starts

2026-06-01

Expected to finish

2032-09-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18 or over
• No history of head and neck radiation
• p53-abnormal IHC patterns (surrogate marker for TP53 mutation)
• Cohort 1:
• Biopsy-confirmed mild/moderate dysplasia
• Cohort 2:
• Biopsy-confirmed severe dysplasia or CIS
• Cohort 3:
• T1 SCC with depth of Invasion (DOI) <4mm
• Clinically and radiologically node-negative (confirmed by contrast-enhanced CT)

You may not qualify if…

• Immunocompromised status
• Lesions greater than 3 cm
• Presence of Proliferative Verrucous Leukoplakia
• Cohort 1:
• Had prior treatment for oral premalignant lesions
• Cohort 2:
• Presence of invasive SCC on initial biopsy
• Cohort 3:
• Positive nodes on contrast-enhanced CT
• DOI >= 4mm

Where it is running

• Vancouver General Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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