Leukoplakia, OralNCT04858100
Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
A study testing Surgical excision of the lesion and Wait and see approach in people with Leukoplakia, Oral, run by University of Milan at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukoplakia, Oral
- What is being tested?
- Surgical excision of the lesion and Wait and see approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2020to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
University of Milan
Milan, 20142
Giovanni Lodi, 003950319021, giovanni.lodi@unimi.it
- Recruiting
Università degli Studi di Torino Dental School
Turin, TO, 10126
Paolo Arduino, DDS, paologiacomo.arduino@unito.it
Paolo Arduino, DDS
About this study
Official title: Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
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.
Read the detailed description
Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.
A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.
The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.
- Conditions
- Leukoplakia, Oral
- Being tested
- Surgical excision of the lesion, Wait and see approach
- Keywords
- Oral Potentially Malignant Disorder, Oral carcinoma, Oral medicine, Cancer prevention
- Medical subject headings
- Leukoplakia, Oral, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical excision of the lesionProcedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Each patient will receive the surgical excision of the lesion and subsequent follow-up Receives: 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. Receives: Other: Wait and see approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral cancer incidence
Number of patients who will develop oral squamous cell carcinoma
Measured: every 3 or 6 months (according to the clinical case) up to 5 years
Secondary outcomes (2)
Time to malignant transformation from diagnosis
Period of time required to develop malignancy
Measured: every 3 or 6 months (according to clinical case) up to 5 years
Quality of life after surgical excision
To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow.
Measured: month 1 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Sep 2020
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukoplakia, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Lodi, University of Milan
- Investigators
- Giovanni Lodi, PhD, DMD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858100
- Sponsor's protocol ID
- LEUKO2020
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04858100
- Acronym / sponsor ID
- LEUKO2020
- Conditions
- Leukoplakia, Oral
- Keywords
- Oral Potentially Malignant Disorder, Oral carcinoma, Oral medicine, Cancer prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.
A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.
The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Surgical excision of the lesionEach patient will receive the surgical excision of the lesion and subsequent follow-up |
| Wait and see | Active comparator | Other: Wait and see approachEach patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical excision of the lesionThe 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. | Procedure or surgery | Surgery |
| Wait and see approachThe 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. | Other | Wait and see |
Primary outcome
Oral cancer incidence
Time frame: every 3 or 6 months (according to the clinical case) up to 5 years
Number of patients who will develop oral squamous cell carcinoma
2 secondary outcomes
Time to malignant transformation from diagnosis
Time frame: every 3 or 6 months (according to clinical case) up to 5 years
Quality of life after surgical excision
Time frame: month 1 and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Lodi, PhD, DMD principal investigator
University of Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical excision of the lesion and Wait and see approach in people with Leukoplakia, Oral, run by University of Milan at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Lodi, PhD, DMD (00390250319021, giovanni.lodi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral cancer incidence (time frame: every 3 or 6 months (according to the clinical case) up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.