How to treat p53-mutant oral precancers and early oral cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with p53-abnormal oral epithelial lesions, ranging from mild/moderate dysplasia to early squamous cell carcinoma (T1, DOI <4 mm) without nodal involvement. Participants are assigned to one of three cohorts with varying surgical and margin strategies, including excision alone, excision with neck surgery, and combination approaches with close follow-up. The trial aims to determine the optimal treatment at each diagnostic stage to reduce progression to invasive cancer and improve disease-free and overall survival. Eligibility requires no prior head and neck radiation, no lesions >3 cm, and specific p53 abnormal IHC patterns. The study is led by the University of British Columbia with site at Vancouver General Hospital in Canada.

Why it matters

Who can join: the full rules

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

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Eitan Prisman
• Email: prisman.eitan@vch.ca
• Phone: 6048754126

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.