Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors: A Randomized Controlled Trial
NCT ID: NCT07090070
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
171 participants
INTERVENTIONAL
2025-09-30
2032-09-30
Brief Summary
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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 END if development of nodal disease
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: p53 mutant mild/moderate dysplasia observational group
Observation only
No interventions assigned to this group
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
Cohort 1 Intervention group
Clear 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
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
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 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Cohort 2 p53 and severe/CIS margins clear
Excision of the lesion ensuring final negative p53 and severe/CIS margins
Cohort 3: p53 mutant T1 SCC (DOI 0-3mm) excision and END group
Excision of primary lesion with 5+ mm margins and immediate elective neck dissection (END)
Cohort 3 Excision and END
Excision of primary lesions with 5+mm margins and immediate elective neck dissection
Cohort 3: p53 mutant T1 SCC (DOI 0-3mm) excision and follow up group
Excision of primary lesion with 5+mm margins and close follow up with salvage elective neck dissection (END) if development of nodal disease
Cohort 3 Excision and Close follow up
Excision of primary lesion with 5+mm margins and close follow up with salvage elective neck dissection if development of nodal disease
Interventions
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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 lesions with 5+mm margins and immediate elective neck dissection
Cohort 3 Excision and Close follow up
Excision of primary lesion with 5+mm margins and close follow up with salvage elective neck dissection if development of nodal disease
Eligibility Criteria
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Inclusion Criteria
Cohort 1:
* Biopsy-confirmed mild/moderate dysplasia with p53 mutations (tested via IHC)
* No prior treatment for oral premalignant lesions
* No clinical evidence of SCC
Cohort 2:
* Biopsy-confirmed severe dysplasia or CIS with p53 mutation (tested via IHC)
Cohort 3:
* T1 SCC with p53 mutation (tested via IHC)
* Depth of Invasion (DOI) 0-3mm
* Clinically and radiologically node-negative (confirmed by contrast-enhanced CT)
Exclusion Criteria
* Immunocompromised status
* Location of excision would be functionally morbid
* Lesions greater than 3cm
* Presence of Proliferative Verrucous Leukoplakia
Cohort 1:
* Severe dysplasia or carcinoma is situ (CIS) on initial biopsy
Cohort 2:
* Presence of invasive SCC on initial biopsy
Cohort 3:
* Positive nodes on imaging
* DOI \>= 4mm
18 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Eitan Prisman
Principal Investigator
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Liu 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.
Durham 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.
Hyodo 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.
Lin 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.
Gleber-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.
Liu 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.
Novack 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.
Ko 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.
Other Identifiers
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H25-01056
Identifier Type: -
Identifier Source: org_study_id
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