Comparing 5 approaches for oral epithelial dysplasia (OED)
Official title: Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
- 6 groups
- One site, in Vancouver
- Recruiting
Interventions (5)
- Medical procedure
Cohort 1 Intervention group
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
- Medical procedure
Cohort 2 severe/CIS margins clear
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
- Medical procedure
Cohort 2 p53 and severe/CIS margins clear
Excision of the lesion ensuring final negative p53 and severe/CIS margins
- Medical procedure
Cohort 3 Excision and END
Excision of primary lesion and immediate elective neck dissection
- Medical procedure
Cohort 3 Excision and Close follow up
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adults age 18 or over
- +p53-abnormal IHC patterns (surrogate marker for TP53 mutation)
- +Biopsy-confirmed mild/moderate dysplasia
- +Biopsy-confirmed severe dysplasia or CIS
- +T1 SCC with depth of Invasion (DOI) \<4mm
- +Clinically and radiologically node-negative (confirmed by contrast-enhanced CT)
- +No history of head and neck radiation
Exclusion
- −Immunocompromised status
- −Lesions greater than 3 cm
- −Presence of Proliferative Verrucous Leukoplakia
- −Had prior treatment for oral premalignant lesions
- −Presence of invasive SCC on initial biopsy
- −Positive nodes on contrast-enhanced CT
- −DOI \>= 4mm
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Group A receives no study treatment and is followed for comparison.
Registry label: A: Cohort 1: p53 mutant mild/moderate dysplasia observational group
Group B receives CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1 Intervention group.
Registry label: B: Cohort 1: p53 mutant mild/moderate dysplasia excision group
Group C, the comparison group, receives Cohort 2 severe/CIS margins clear.
Registry label: C: Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group
Group D receives Cohort 2 p53 and severe/CIS margins clear.
Registry label: D: Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group
Group E, the comparison group, receives Cohort 3 Excision and END.
Registry label: E: Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group
Group F receives Cohort 3 Excision and Close follow upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Registry label: F: Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 636 people.
The study is currently expected to finish around September 2032.
The main measurement is taken over: 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression of Disease — measured over 4 years.
Time of Disease Progression — measured over 4 years.
Recurrence of Disease — measured over Study 1 and 2: 4 years, Study 3: 3 years.
Disease-free Survival — measured over 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07090070 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Cohort 1 Intervention groupProcedure
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cohort 2 severe/CIS margins clearProcedure
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cohort 2 p53 and severe/CIS margins clearProcedure
Excision of the lesion ensuring final negative p53 and severe/CIS margins
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cohort 3 Excision and ENDProcedure
Excision of primary lesion and immediate elective neck dissection
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cohort 3 Excision and Close follow upProcedure
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4 years.
The study as a whole is currently expected to finish around 2032-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 636 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.