Speech-based AI-driven Diagnostics and Rehabilitation for Oral and Oropharyngeal Cancer.

NCT ID: NCT07347899

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 501 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2022-12-31

Brief Summary

Participants diagnosed with oral cancer, oropharyngeal cancer, or oral potentially malignant lesions, as well as healthy controls, had their speech audio recordings collected for the development and validation of AI-driven models for diagnosis and prognosis prediction of oral cancer and oropharyngeal cancer.

Detailed Description

Participants were instructed to articulate three sustained vowels (/a/, /i/, /u/) repeatedly at a moderate volume and pace, with three repetitions per vowel and each utterance lasting at least one second. We developed a neuromorphic computing framework that orthogonally decomposes acoustic features into ultra-dimensional omics representations, enabling the characterization of both localized lesions and systemic physiological conditions. The study collected a comprehensive spectrum of biological profiles, including sociodemographic characteristics, tumor metrics, oral function-related factors, patient-reported outcome measures (PROMs), immunoinflammatory indices, and general health status indicators, to thoroughly investigate the paralinguistic representations of transformed speech omics features. These features were then rigorously evaluated for their clinical efficacy across multiple diagnostic tasks, including screening, early detection, pathological diagnosis, disease staging, and risk factor identification.

Conditions

Oral Cancer; Oropharyngeal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

healthy control and oral potentially malignant lesion

Speakers with oral potentially malignant lesions or healthy status

No interventions assigned to this group

oral cancer and oropharyngeal cancer

Patients diagnosed with oral cancer or oropharyngeal cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• diagnosed as having OC or OPC regardless of concrete pathological subtype (e.g., epithelial, adenoid, odontogenic)
• without a history of other tumor-related treatment before the initial evaluation, such as radiotherapy and chemotherapy
• native Chinese speakers

Exclusion Criteria

• hearing impairment
• history of stuttering, cerebrovascular accident, brain trauma, neurodegenerative diseases
• severe dental or maxillofacial deformity
• cleft lip, cleft palate, and related post-treatment status
• severe cardiology conditions, breathing/pulmonology disorders, psychiatric disorders or other illnesses preventing patients from receiving standard surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yudong Xiao

OTHER

Sponsor Role: lead

Responsible Party

Yudong Xiao

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of oral and maxillofacial surgery, Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ERC-[2014]-35

Identifier Type: -

Identifier Source: org_study_id