NCT07090070Recruiting
Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 636 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- Jul 2026
- Primary completion date
- Jan 2032
- Lead sponsor
- University of British Columbia
- Diseases
- Head and neck cancer
- NCT number
- NCT07090070
What you commit to
- Study type: Interventional
- Planned participants: 636
- From Jul 2026 to the primary completion date, Jan 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior treatment for oral premalignant lesions
- Cohort 2:
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.