NCT04858100

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

5.5 years

First QC Date

March 2, 2021

Last Update Submit

March 5, 2024

Conditions

Leukoplakia, Oral

Keywords

Oral Potentially Malignant DisorderOral carcinomaOral medicineCancer prevention

Outcome Measures

Primary Outcomes (1)

  • Oral cancer incidence

    Number of patients who will develop oral squamous cell carcinoma

    every 3 or 6 months (according to the clinical case) up to 5 years

Secondary Outcomes (2)

  • Time to malignant transformation from diagnosis

    every 3 or 6 months (according to clinical case) up to 5 years

  • Quality of life after surgical excision

    month 1 and month 6

Study Arms (2)

Surgery

EXPERIMENTAL

Each patient will receive the surgical excision of the lesion and subsequent follow-up

Procedure: Surgical excision of the lesion

Wait and see

ACTIVE COMPARATOR

Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.

Other: Wait and see approach

Interventions

Surgical excision of the lesionPROCEDURE

The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps: * local anesthesia * excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 mm-free margins * silk or resorbable suture for wound closure The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam. The patient will receive a 3-6 month follow-up according to the clinical and histopathological case.

Surgery
Wait and see approachOTHER

The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit. In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a "true" malignat progression.

Wait and see

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Università degli Studi di Torino Dental School

Turin, TO, 10126, Italy

RECRUITING

University of Milan

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Leukoplakia, OralMouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsLeukoplakiaPrecancerous ConditionsMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Lodi, PhD, DMD

    University of Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Lodi, PhD, DMD

CONTACT

00390250319021giovanni.lodi@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

April 26, 2021

Study Start

September 1, 2020

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations

IT(2)