Not Yet RecruitingNot Applicable

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

Canada636 participantsStarted 2026-06-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression of Disease

Timeframe: 4 years

Time of Disease Progression

Timeframe: 4 years

Recurrence of Disease

Timeframe: Study 1 and 2: 4 years, Study 3: 3 years

Disease-free Survival

Timeframe: 3 years

Trial details

NCT IDNCT07090070

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-01

Contact for this trial

Eitan Prisman

6048754126 prisman.eitan@vch.ca

View on ClinicalTrials.gov More Oral Epithelial Dysplasia (OED) trials