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

RecruitingNAAges 18 Years - anyAllUniversity of British Columbia
NCT07090070 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 diagn

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📋 Eligibility rules (as published)
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
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What it tests

  • Cohort 1 Intervention group
  • Cohort 2 severe/CIS margins clear
  • Cohort 2 p53 and severe/CIS margins clear
  • Cohort 3 Excision and END
  • Cohort 3 Excision and Close follow up
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Where

1 site
Vancouver General Hospital
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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