Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Brak wcześniejszej radioterapii głowy i szyi
- •Potwierdzona mutacja p53 w badaniu patologicznym
- •Dla grupy 1: Łagodne lub umiarkowane zmiany dysplazyjne potwierdzone biopsją
- •Dla grupy 2: Ciężkie zmiany dysplazyjne lub zaawansowana dysplazja potwierdzona biopsją
- •Dla grupy 3: Wczesny rak ust (T1) o głębokości wnikania poniżej 4 mm, bez przerzutów do węzłów chłonnych
✗ Disqualifies
- •Osłabiony system immunologiczny
- •Zmiany większe niż 3 cm
- •Obecność brodawkowatej leukoplakii
- •Dla grupy 1: Wcześniejsze leczenie zmian przedrakowatych w jamie ustnej
- •Dla grupy 2: Obecność invasyjnego raka ust w wstępnej biopsji
- •Dla grupy 3: Przerzuty do węzłów chłonnych, głębokość wnikania 4 mm lub większa
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Vancouver General Hospital
Vancouver, Canada
Trial contact
Eitan Prisman
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/9/2026.
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