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

NCT07347899 | Completed DMC

• 1 other identifier: ERC-[2014]-35
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Oropharyngeal Cancer

Keywords

speech signal analysis; diagnostic models; vowel acoustics; bio-inspired computing

Outcome Measures

Primary Outcomes (1)

• AUC value

  Area under the receiver operating characteristic curve (AUC) for discriminating OC/OPC from healthy controls

  From enrollment to the report of surgical pathology，up to two weeks.

Study Arms (2)

healthy control and oral potentially malignant lesion

Speakers with oral potentially malignant lesions or healthy status

oral cancer and oropharyngeal cancer

Patients diagnosed with oral cancer or oropharyngeal cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only participants whose self-identified gender aligns with their assigned sex at birth will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-patient participants diagnosed with oral cancer, oropharyngeal cancer or oral potentially malignant lesion and healthy volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yudong Xiao: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510055, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

speech samples will be recorded and saved with anonymization.

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 16, 2026
• Study Start: July 17, 2017
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: permanent valid

Locations

CN (1)