Clinical trial · Interventional
Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Epithelial Dysplasia (OED) | — | UNRESOLVED | — |
| Oral Squamous Cell Carcinoma (SCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort 1 Intervention group | Procedure | — | UNRESOLVED |
| Cohort 2 p53 and severe/CIS margins clear | Procedure | — | UNRESOLVED |
| Cohort 2 severe/CIS margins clear | Procedure | — | UNRESOLVED |
| Cohort 3 Excision and Close follow up | Procedure | — | UNRESOLVED |
| Cohort 3 Excision and END | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Cohort 1: p53 mutant mild/moderate dysplasia observational group
- description
- Observation only
- type
- EXPERIMENTAL
- label
- Cohort 1: p53 mutant mild/moderate dysplasia excision group
- description
- Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins
- interventionNames
- Procedure: Cohort 1 Intervention group
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group
- description
- Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDD'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. PMID 26027881
- BACKGROUNDLiu 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. PMID 27560665
- BACKGROUNDDurham 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. PMID 33034628
- BACKGROUNDHyodo 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. PMID 36522371
- BACKGROUNDLin 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. PMID 39265952
- BACKGROUNDGleber-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.