Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors: A Randomized Controlled Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

January 31, 2032

Study Completion Date

September 30, 2032

Conditions
Oral Epithelial Dysplasia (OED)Oral Squamous Cell Carcinoma (SCC)
Interventions
PROCEDURE

Cohort 1 Intervention group

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

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

PROCEDURE

Cohort 2 p53 and severe/CIS margins clear

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

PROCEDURE

Cohort 3 Excision and END

Excision of primary lesions with 5+mm margins and immediate elective neck dissection

PROCEDURE

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

Trial Locations (1)

Unknown

Vancouver General Hospital, Vancouver

All Listed Sponsors
lead

University of British Columbia

OTHER