Clinical trial · Interventional
Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
NCT04858100CI-TRIAL-00074809unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukoplakia, Oral | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical excision of the lesion | Procedure | — | UNRESOLVED |
| Wait and see approach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery
- description
- Each patient will receive the surgical excision of the lesion and subsequent follow-up
- interventionNames
- Procedure: Surgical excision of the lesion
- type
- ACTIVE_COMPARATOR
- label
- Wait and see
- description
- Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.
- interventionNames
- Other: Wait and see approach
Primary outcomes (1)
- measure
- Oral cancer incidence
- timeFrame
- every 3 or 6 months (according to the clinical case) up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.