Artificial Intelligence for the Diagnosis of Oral Lesions (AID-OraL)

April 13, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Squamous cell carcinomas of the upper aerodigestive tract are among the most common cancers worldwide, with the oral cavity being the most frequent site. Oral cavity squamous cell carcinomas (OCSCC) represent a major cause of morbidity and mortality, mainly due to high rates of locoregional or metastatic recurrence and the frequent occurrence of second primary tumors. Unlike oropharyngeal squamous cell carcinomas, human papillomavirus (HPV) is not involved in the carcinogenesis of OCSCC.

In some cases, OCSCC develop from oral potentially malignant disorders (OPMDs), such as leukoplakia and erythroplakia, which have a worldwide incidence of 3-5%. The malignant transformation rate of OPMDs ranges from 3% to 50%, reflecting their marked heterogeneity. Although several clinical, histological, and molecular factors have been proposed to identify patients at high risk of malignant transformation, none have demonstrated sufficient clinical utility to date. In other cases, OCSCC arise from clinically normal oral mucosa in patients with OPMDs located at a distance and/or with established risk factors, particularly tobacco and alcohol use.

Currently, no chemopreventive or preventive strategy has been established as a standard of care to prevent malignant transformation of OPMDs. Improving the prognosis of OCSCC therefore requires the development of tools to better identify high-risk OPMDs and to enable the earliest possible diagnosis. Early detection of OPMDs is essential for secondary prevention of OCSCC. However, conventional oral examination based on visual inspection and palpation has limited sensitivity, and clinical recognition of OPMDs remains challenging. Consequently, there is a clear need for improved methods to enhance early detection and risk stratification of OPMDs.

Main objective:

To develop a tool to aid in the diagnosis of cancerous lesions in the oral cavity using Artificial Intelligence (AI). This tool appears promising in meeting the current needs of the oral cavity practitioner community.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients followed in the Department of Oral Mucosal Pathology (Maxillofacial Surgery and Stomatology Department, Pitié-Salpêtrière Hospital, AP-HP, Paris) from January 1, 1970, to December 31, 2023, with a diagnosis of potentially malignant oral lesions and/or oral cavity cancer.

Description

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patients followed up in the Oral Mucosa Pathology Department (Maxillofacial Surgery and Stomatology Department, Pitié-Salpêtrière Hospital, AP-HP, Paris) between January 1, 1970, and December 31, 2023, with a diagnosis of potentially malignant oral lesion and/or oral cavity cancer.

Exclusion Criteria:

  • Photograph of the lesion unavailable (in standard care)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a tool to aid in the diagnosis of cancerous lesions in the oral cavity using Artificial Intelligence (AI)
Time Frame: Through study completion, an average of 9 months

To develop a tool to aid in the diagnosis of cancerous lesions in theoral cavity using Artificial Intelligence (AI). This tool appears promisingin meeting the current needs of the oral cavity practitioner community.

To achieve this objective, anonymized clinical photographs of oral lesions, along with relevant clinical data routinely recorded in medical charts, will be collected.

All photographs will undergo retrospective review by experienced specialists in oral and maxillofacial surgery. The experts will independently assess the images and establish a reference diagnosis. In cases of disagreement, a consensus diagnosis will be reached.

The complete dataset, including image data, associated clinical variables, and reference diagnoses, will be used to develop and internally validate a machine learning algorithm for the automated classification of oral lesions
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

BPIfrance
Institut Universitaire de Cancérologie, Sorbonne University
Health Data Hub (France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251103
  • CEth-SCOMFS 003/2025 (Other Identifier: Ethics Committee of the French Society of Stomatology, Maxillofacial Surgery and Oral Surgery)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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