An interventional study of Cohort 1 Intervention group and Cohort 2 severe/CIS margins clear in Oral Epithelial Dysplasia (OED) and Oral Squamous Cell Carcinoma (SCC), sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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
Cohort 1:
Cohort 2:
Cohort 3:
Exclusion Criteria:
Cohort 1:
Cohort 2:
Cohort 3:
Observation only
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins
Procedure: Cohort 1 Intervention group
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
Procedure: Cohort 2 severe/CIS margins clear
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Procedure: Cohort 2 p53 and severe/CIS margins clear
Excision of primary lesion and immediate elective neck dissection (END)
Procedure: Cohort 3 Excision and END
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
Procedure: Cohort 3 Excision and Close follow up
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Excision of primary lesion and immediate elective neck dissection
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
Progression of Disease
Study 1: Whether diagnosis progressed from low-grade dysplasia (mild/moderate OED) to high-grade (severe/CIS) dysplasia or OSCC. Study 2: Whether diagnosis progressed from high-grade (severe/CIS) dysplasia to OSCC.
Time frame: 4 years
Time of Disease Progression
Study 1: Time for disease to progress from low-grade dysplasia (mild/moderate OED) to high-grade (severe/CIS) dysplasia or OSCC. Study 2: Time for disease to progress from high-grade (severe/CIS) dysplasia to OSCC.
Time frame: 4 years
Recurrence of Disease
Study 1: Whether recurrence of low-grade dysplasia is present. Study 2: Whether recurrence of high-grade dysplasia is present. Study 3: Whether recurrence of OSCC is present, and if recurrence pattern is local recurrence or nodal metastasis. All: Time for disease to recur.
Time frame: Study 1 and 2: 4 years, Study 3: 3 years
Disease-free Survival
Study 3: If survival is achieved disease-free following treatment.
Time frame: 3 years
Overall survival
Overall survival is measured as survival for 4 years following diagnosis and treatment. Cause of death will be included, if applicable.
Time frame: Study 1 and 2: 4 years, Study 3: 3 years
Patient Reported Outcomes - Quality of Life and Functional Measurements
Patient quality of life: 1. Oral Health Impact Profile-14 (OHIP) - 14 questions on a 5 point Likert scale (0-4), total ranging from 0-56, with higher scores indicating worse quality of life. 2. Hospital Anxiety and Depression Scale (HADS) - 14 questions on a 4 point Likert scale (0-3), total ranging from 0-21, with higher scores indicating increased severity or probability of depression and anxiety. Functional measurement: 1\. MD Anderson Dysphagia Inventory (MDADI) - 20 questions on a 5 point Likert scale (1-5), score total ranging from 20-100, with lower scores indicating more severe limitations.
Time frame: Study 1 and 2: 4 years, Study 3: 3 years
Plan to share: Undecided
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University of British Columbia