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

NCT07090070 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-02-17

No results posted yet for this study

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 (SCC). 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 without surgical intervention will progress to high-grade dysplasia 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\<3mm 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 END if development of nodal disease

Conditions

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

Interventions

PROCEDURE

Cohort 1 Intervention group

Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.

PROCEDURE

Cohort 2 severe/CIS margins clear

Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear

PROCEDURE

Cohort 2 p53 and severe/CIS margins clear

Excision of the lesion ensuring final negative p53 and severe/CIS margins

PROCEDURE

Cohort 3 Excision and END

Excision of primary lesions with 5+mm margins and immediate elective neck dissection

PROCEDURE

Cohort 3 Excision and Close follow up

Excision of primary lesion with 5+mm margins and close follow up with salvage elective neck dissection if development of nodal disease

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2032-01-31
Completion
2032-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090070 on ClinicalTrials.gov