Testing Treatments for p53-Mutant Mouth Lesions and Early Mouth Cancer
Tests treatment options in adults with p53-mutant precancerous or early mouth cancer lesions.
Plain-language title generated from the registry record
Registry title: Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Key facts
- Where
- Vancouver, CanadaSee the site
Where in Canada
- Vancouver General HospitalVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of British Columbia
- Trial code
- NCT07090070
- Record updated
- 8 September 2026
- Original description
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.Read full original descriptionShow less
Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
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
Inclusion: 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: Had prior treatment for oral premalignant lesions; Cohort 2:; Immunocompromised status; Lesions greater than 3 cm; Presence of Proliferative Verrucous Leukoplakia; Cohort 1:; Presence of invasive SCC on initial biopsy; Cohort 3:; Positive nodes on contrast-enhanced CT; DOI >= 4mm.