Recruiting

OED & OSCCEvaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors

Sponsor:

University of British Columbia

Code:

NCT07090070

Conditions

Oral Epithelial Dysplasia (OED)

Oral Squamous Cell Carcinoma (SCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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<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

Conditions

Oral Epithelial Dysplasia (OED)

Oral Squamous Cell Carcinoma (SCC)

Study ID

NCT07090070

Start date

Jul 8, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2032

Anticipated

Primary completion date

Jan, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

636 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Cohort 1: p53 mutant mild/moderate dysplasia observational group

Observation only

experimental: Cohort 1: p53 mutant mild/moderate dysplasia excision group

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

active comparator: Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group

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

experimental: Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group

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

active comparator: Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group

Excision of primary lesion and immediate elective neck dissection (END)

experimental: Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group

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

Interventions

Cohort 1 Intervention group

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

Cohort 2 severe/CIS margins clear

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

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

Cohort 3 Excision and END

Excision of primary lesion and immediate elective neck dissection

Cohort 3 Excision and Close follow up

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

Primary outcome measure

Progression of Disease [ Time Frame: 4 years ]
Time of Disease Progression [ Time Frame: 4 years ]
Recurrence of Disease [ Time Frame: Study 1 and 2: 4 years, Study 3: 3 years ]
Disease-free Survival [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Eitan Prisman

6048754126 prisman.eitan@vch.ca

Alan Wei

6048754111 alan.wei@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Eitan Prisman

6048754126 eitan.prisman@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

p53 mutant
SCC
oral epithelial dysplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-09-08.