An observational study in Oral Potentially Malignant Disorders and Oral Cavity Squamous Cell Carcinoma, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 100 across 179 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Develop a tool to aid in the diagnosis of cancerous lesions in the oral cavity using Artificial Intelligence (AI)
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
Time frame: Through study completion, an average of 9 months
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Squamous Cell Carcinoma of Head and Neck→
Assistance Publique - Hôpitaux de Paris