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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of British Columbia • ClinicalTrials.gov ID: NCT07090070

Registry updated: 2026-09-08
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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. 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

Interventions

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

Eligibility criteria

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

Conditions

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

Locations

  • Vancouver General Hospital — Vancouver, British Columbia, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record