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Recruiting
NCT07090070
Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Conditions: Oral Epithelial Dysplasia (OED), Oral Squamous Cell Carcinoma (SCC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 636
Sponsor: University of British Columbia
Location: Vancouver General Hospital Vancouver British Columbia
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 (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\
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
Source: ClinicalTrials.gov (NCT07090070). StuddyBuddy aggregates publicly available trial information.