Oral Epithelial Dysplasia (OED)p53 RCTNCT07090070
Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
A study testing Cohort 1 Intervention group, Cohort 2 severe/CIS margins clear and Cohort 2 p53 and severe/CIS margins clear in people with Oral Epithelial Dysplasia (OED) and Oral Squamous Cell Carcinoma (SCC), run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Epithelial Dysplasia (OED), Oral Squamous Cell Carcinoma (SCC)
- What is being tested?
- Cohort 1 Intervention group, Cohort 2 severe/CIS margins clear and Cohort 2 p53 and severe/CIS margins clear
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2026to Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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)
Who cannot join
- Immunocompromised status
- Lesions greater than 3 cm
- Presence of Proliferative Verrucous Leukoplakia
- Cohort 1:
- Had prior treatment for oral premalignant lesions
- Cohort 2:
Show all 10Show fewer
- Presence of invasive SCC on initial biopsy
- Cohort 3:
- Positive nodes on contrast-enhanced CT
- DOI >= 4mm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Eitan Prisman, 6048754126, eitan.prisman@ubc.ca
About this study
Official title: Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
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:
Read more
Cohort 1:
- No intervention, observation only B) Surgical excision with clear margins
Cohort 2:
- Surgical excision with clear severe/CIS margins B) Surgical excision with clear severe/CIS and p53 margins
Cohort 3:
- Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease
- Being tested
- 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
- Keywords
- p53 mutant, SCC, oral epithelial dysplasia
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 Intervention groupProcedure or surgery
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.
Cohort 2 severe/CIS margins clearProcedure or surgery
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 clearProcedure or surgery
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Cohort 3 Excision and ENDProcedure or surgery
Excision of primary lesion and immediate elective neck dissection
Cohort 3 Excision and Close follow upProcedure or surgery
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: p53 mutant mild/moderate dysplasia observational group | No intervention | Observation only |
| Cohort 1: p53 mutant mild/moderate dysplasia excision group | Experimental | Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins Receives: Procedure: Cohort 1 Intervention group |
| Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group | Active comparator | Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear Receives: Procedure: Cohort 2 severe/CIS margins clear |
| Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group | Experimental | Excision of the lesion ensuring final negative p53 and severe/CIS margins Receives: Procedure: Cohort 2 p53 and severe/CIS margins clear |
| Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group | Active comparator | Excision of primary lesion and immediate elective neck dissection (END) Receives: Procedure: Cohort 3 Excision and END |
| Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group | Experimental | Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease Receives: Procedure: Cohort 3 Excision and Close follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Disease
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.
Measured: 4 years
Time of Disease Progression
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.
Measured: 4 years
Recurrence of Disease
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.
Measured: Study 1 and 2: 4 years, Study 3: 3 years
Disease-free Survival
Study 3: If survival is achieved disease-free following treatment.
Measured: 3 years
Secondary outcomes (2)
Overall survival
Overall survival is measured as survival for 4 years following diagnosis and treatment. Cause of death will be included, if applicable.
Measured: Study 1 and 2: 4 years, Study 3: 3 years
Patient Reported Outcomes - Quality of Life and Functional Measurements
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.
Measured: Study 1 and 2: 4 years, Study 3: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start8 Jul 2026
- Primary completionJan 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral Epithelial Dysplasia (OED)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eitan Prisman, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090070
- Sponsor's protocol ID
- H25-01056
- Acronym
- p53 RCT
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
PubMed 26027881Liu KY, Durham JS, Wu J, Anderson DW, Prisman E, Poh CF. Nodal Disease Burden for Early-Stage Oral Cancer. JAMA Otolaryngol Head Neck Surg. 2016 Nov 1;142(11):1111-1119. doi: 10.1001/jamaoto.2016.2241.
PubMed 27560665Durham JS, Brasher P, Anderson DW, Yoo J, Hart R, Dort JC, Seikaly H, Kerr P, Rosin MP, Poh CF. Effect of Fluorescence Visualization-Guided Surgery on Local Recurrence of Oral Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Dec 1;146(12):1149-1155. doi: 10.1001/jamaoto.2020.3147.
PubMed 33034628Hyodo T, Kuribayashi N, Fukumoto C, Komiyama Y, Shiraishi R, Kamimura R, Sawatani Y, Yaguchi E, Hasegawa T, Izumi S, Wakui T, Nakashiro KI, Uchida D, Kawamata H. The mutational spectrum in whole exon of p53 in oral squamous cell carcinoma and its clinical implications. Sci Rep. 2022 Dec 15;12(1):21695. doi: 10.1038/s41598-022-25744-8.
PubMed 36522371Lin TY, Liu KYP, Novack R, Mattu PS, Ng TL, Hoang LN, Prisman E, Poh CF, Ko YCK. Abnormal p53 Immunohistochemical Patterns Are Associated with Regional Lymph Node Metastasis in Oral Cavity Squamous Cell Carcinoma at Time of Surgery. Mod Pathol. 2024 Dec;37(12):100614. doi: 10.1016/j.modpat.2024.100614. Epub 2024 Sep 10.
PubMed 39265952Gleber-Netto FO, Neskey D, Costa AFM, Kataria P, Rao X, Wang J, Kowalski LP, Pickering CR, Dias-Neto E, Myers JN. Functionally impactful TP53 mutations are associated with increased risk of extranodal extension in clinically advanced oral squamous cell carcinoma. Cancer. 2020 Oct 15;126(20):4498-4510. doi: 10.1002/cncr.33101. Epub 2020 Aug 14.
PubMed 32797678Liu KYP, Zhu SY, Harrison A, Chen ZY, Guillaud M, Poh CF. Quantitative nuclear phenotype signatures predict nodal disease in oral squamous cell carcinoma. PLoS One. 2021 Nov 4;16(11):e0259529. doi: 10.1371/journal.pone.0259529. eCollection 2021.
PubMed 34735529Novack R, Zhang L, Hoang LN, Kadhim M, Ng TL, Poh CF, Kevin Ko YC. Abnormal p53 Immunohistochemical Patterns Shed Light on the Aggressiveness of Oral Epithelial Dysplasia. Mod Pathol. 2023 Jul;36(7):100153. doi: 10.1016/j.modpat.2023.100153. Epub 2023 Mar 9.
PubMed 36906072Ko YCK, Liu KYP, Chen E, Zhu SY, Poh CF. p53 Abnormal Oral Epithelial Dysplasias are Associated With High Risks of Progression and Local Recurrence-A Retrospective Study in a Longitudinal Cohort. Mod Pathol. 2024 Dec;37(12):100613. doi: 10.1016/j.modpat.2024.100613. Epub 2024 Sep 10.
PubMed 39265950
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
- ClinicalTrials.gov ID
- NCT07090070
- Acronym / sponsor ID
- p53 RCT / H25-01056
- Keywords
- p53 mutant, SCC, oral epithelial dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- No intervention, observation only B) Surgical excision with clear margins
Cohort 2:
- Surgical excision with clear severe/CIS margins B) Surgical excision with clear severe/CIS and p53 margins
Cohort 3:
- Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: p53 mutant mild/moderate dysplasia observational group | No intervention | –Observation only |
| Cohort 1: p53 mutant mild/moderate dysplasia excision group | Experimental | Procedure: Cohort 1 Intervention groupClear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins |
| Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group | Active comparator | Procedure: Cohort 2 severe/CIS margins clearClear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear |
| Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group | Experimental | Procedure: Cohort 2 p53 and severe/CIS margins clearExcision of the lesion ensuring final negative p53 and severe/CIS margins |
| Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group | Active comparator | Procedure: Cohort 3 Excision and ENDExcision of primary lesion and immediate elective neck dissection (END) |
| Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group | Experimental | Procedure: Cohort 3 Excision and Close follow upExcision of primary lesion and close follow up with salvage neck dissection if development of nodal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults age 18 or over
- No history of head and neck radiation
- p53-abnormal IHC patterns (surrogate marker for TP53 mutation)
- Biopsy-confirmed mild/moderate dysplasia
- Biopsy-confirmed severe dysplasia or CIS
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 Intervention groupClear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins. | Procedure or surgery | Cohort 1: p53 mutant mild/moderate dysplasia excision group |
| Cohort 2 severe/CIS margins clearClear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear | Procedure or surgery | Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group |
| Cohort 2 p53 and severe/CIS margins clearExcision of the lesion ensuring final negative p53 and severe/CIS margins | Procedure or surgery | Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group |
| Cohort 3 Excision and ENDExcision of primary lesion and immediate elective neck dissection | Procedure or surgery | Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group |
| Cohort 3 Excision and Close follow upExcision of primary lesion and close follow up with salvage neck dissection if development of nodal disease | Procedure or surgery | Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group |
Primary outcome
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.
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.
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.
Disease-free Survival
Time frame: 3 years
Study 3: If survival is achieved disease-free following treatment.
2 secondary outcomes
Overall survival
Time frame: Study 1 and 2: 4 years, Study 3: 3 years
Patient Reported Outcomes - Quality of Life and Functional Measurements
Time frame: Study 1 and 2: 4 years, Study 3: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 26027881D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
- Background: PubMed 27560665Liu KY, Durham JS, Wu J, Anderson DW, Prisman E, Poh CF. Nodal Disease Burden for Early-Stage Oral Cancer. JAMA Otolaryngol Head Neck Surg. 2016 Nov 1;142(11):1111-1119. doi: 10.1001/jamaoto.2016.2241.
- Background: PubMed 33034628Durham JS, Brasher P, Anderson DW, Yoo J, Hart R, Dort JC, Seikaly H, Kerr P, Rosin MP, Poh CF. Effect of Fluorescence Visualization-Guided Surgery on Local Recurrence of Oral Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Dec 1;146(12):1149-1155. doi: 10.1001/jamaoto.2020.3147.
- Background: PubMed 36522371Hyodo T, Kuribayashi N, Fukumoto C, Komiyama Y, Shiraishi R, Kamimura R, Sawatani Y, Yaguchi E, Hasegawa T, Izumi S, Wakui T, Nakashiro KI, Uchida D, Kawamata H. The mutational spectrum in whole exon of p53 in oral squamous cell carcinoma and its clinical implications. Sci Rep. 2022 Dec 15;12(1):21695. doi: 10.1038/s41598-022-25744-8.
- Background: PubMed 39265952Lin TY, Liu KYP, Novack R, Mattu PS, Ng TL, Hoang LN, Prisman E, Poh CF, Ko YCK. Abnormal p53 Immunohistochemical Patterns Are Associated with Regional Lymph Node Metastasis in Oral Cavity Squamous Cell Carcinoma at Time of Surgery. Mod Pathol. 2024 Dec;37(12):100614. doi: 10.1016/j.modpat.2024.100614. Epub 2024 Sep 10.
- Background: PubMed 32797678Gleber-Netto FO, Neskey D, Costa AFM, Kataria P, Rao X, Wang J, Kowalski LP, Pickering CR, Dias-Neto E, Myers JN. Functionally impactful TP53 mutations are associated with increased risk of extranodal extension in clinically advanced oral squamous cell carcinoma. Cancer. 2020 Oct 15;126(20):4498-4510. doi: 10.1002/cncr.33101. Epub 2020 Aug 14.
- Background: PubMed 34735529Liu KYP, Zhu SY, Harrison A, Chen ZY, Guillaud M, Poh CF. Quantitative nuclear phenotype signatures predict nodal disease in oral squamous cell carcinoma. PLoS One. 2021 Nov 4;16(11):e0259529. doi: 10.1371/journal.pone.0259529. eCollection 2021.
- Background: PubMed 36906072Novack R, Zhang L, Hoang LN, Kadhim M, Ng TL, Poh CF, Kevin Ko YC. Abnormal p53 Immunohistochemical Patterns Shed Light on the Aggressiveness of Oral Epithelial Dysplasia. Mod Pathol. 2023 Jul;36(7):100153. doi: 10.1016/j.modpat.2023.100153. Epub 2023 Mar 9.
- Background: PubMed 39265950Ko YCK, Liu KYP, Chen E, Zhu SY, Poh CF. p53 Abnormal Oral Epithelial Dysplasias are Associated With High Risks of Progression and Local Recurrence-A Retrospective Study in a Longitudinal Cohort. Mod Pathol. 2024 Dec;37(12):100613. doi: 10.1016/j.modpat.2024.100613. Epub 2024 Sep 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohort 1 Intervention group, Cohort 2 severe/CIS margins clear and Cohort 2 p53 and severe/CIS margins clear in people with Oral Epithelial Dysplasia (OED) and Oral Squamous Cell Carcinoma (SCC), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eitan Prisman (6048754126, prisman.eitan@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Disease (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07090070, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.