Comparing surgery to observation for treating oral leukoplakia
Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
This study is testing whether surgery or just monitoring is better for treating oral leukoplakia and preventing it from turning into cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 2 sites (Turin, TO and 1 other locations) |
| Trial ID | NCT04858100 on ClinicalTrials.gov |
What this trial studies
This research compares the effectiveness of surgical excision versus a 'wait and see' approach for managing oral leukoplakia and erythroleukoplakia, which are conditions that can lead to oral squamous cell carcinoma. The study aims to determine whether surgical intervention can more effectively prevent the onset of cancer compared to regular monitoring. It includes a follow-up period of five years to assess outcomes. This is the first randomized clinical trial to evaluate these two approaches in both dysplastic and nondysplastic cases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of oral leukoplakia and lesions that meet specific size and location criteria.
Not a fit: Patients with a history of oral cancer, those under 18, or individuals at high risk for surgical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the best management strategies for patients with oral leukoplakia, potentially reducing the risk of cancer.
How similar studies have performed: While there have been studies on the management of oral leukoplakia, this trial is novel as it is the first randomized controlled trial directly comparing surgical treatment to a wait-and-see approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis * Subjects' age: 18 years or older * Lesions' size: 3 cm maximum longitudinal size of the single lesion * Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries. * Ability to understand and to sign a written informed consent document Exclusion Criteria: * Previous oral cancer * Head and neck radiotherapy * Subjects under the age of 18 * Subjects affected by PVL (proliferative verrucous leukoplakia) * High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries
Where this trial is running
Turin, TO and 1 other locations
- Università degli Studi di Torino Dental School — Turin, To, Italy (Recruiting)
- University of Milan — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni Lodi, PhD, DMD — University of Milan
- Study coordinator: Giovanni Lodi, PhD, DMD
- Email: giovanni.lodi@unimi.it
- Phone: 00390250319021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.