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NCT Number: NCT07090070

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

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

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Key information

Conditions

Oral Epithelial Dysplasia (OED) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Squamous Cell Carcinoma (SCC) Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1 Intervention group

Procedure

Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.

Cohort 2 severe/CIS margins clear

Procedure

Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear

Cohort 2 p53 and severe/CIS margins clear

Procedure

Excision of the lesion ensuring final negative p53 and severe/CIS margins

Cohort 3 Excision and END

Procedure

Excision of primary lesion and immediate elective neck dissection

Cohort 3 Excision and Close follow up

Procedure

Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease

Primary outcomes

  1. Progression of Disease

    Time frame: 4 years

    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.

  2. Time of Disease Progression

    Time frame: 4 years

    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.

  3. Recurrence of Disease

    Time frame: Study 1 and 2: 4 years, Study 3: 3 years

    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.

  4. Disease-free Survival

    Time frame: 3 years

    Study 3: If survival is achieved disease-free following treatment.

Secondary outcomes

  1. Overall survival

    Time frame: Study 1 and 2: 4 years, Study 3: 3 years

    Overall survival is measured as survival for 4 years following diagnosis and treatment. Cause of death will be included, if applicable.

  2. Patient Reported Outcomes - Quality of Life and Functional Measurements

    Time frame: Study 1 and 2: 4 years, Study 3: 3 years

    Patient quality of life:

    • 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.
    • 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:

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eitan Prisman

CONTACT

[email protected]

6048754126

Tayo Steininger

CONTACT

[email protected]

6048754111 ext. 22935

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study

Acronym: p53 RCT

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 29, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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