Recruiting NA Oral Epithelial Dysplasia (OED)

Clinical trial for Oral Epithelial Dysplasia (OED)

Official title Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors

ClinicalTrials.gov ID: NCT07090070

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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:

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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:
  • 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)
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Vancouver, British Columbia, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.