- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347899
Speech-based AI-driven Diagnostics and Rehabilitation for Oral and Oropharyngeal Cancer. (speech omics)
January 11, 2026 updated by: Yudong Xiao
A Preliminary Study on the Phonetics of Resonance and Articulation Disorders Caused by Defects of the Oral and Maxillofacial Speech Organs and Speech Therapy
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
501
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510055
- Department of oral and maxillofacial surgery, Hospital of Stomatology, Sun Yat-sen University
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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
Yes
Sampling Method
Non-Probability Sample
Study Population
In-patient participants diagnosed with oral cancer, oropharyngeal cancer or oral potentially malignant lesion and healthy volunteers.
Description
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
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
Cohorts and Interventions
Group / Cohort |
|---|
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healthy control and oral potentially malignant lesion
Speakers with oral potentially malignant lesions or healthy status
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oral cancer and oropharyngeal cancer
Patients diagnosed with oral cancer or oropharyngeal cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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AUC value
Time Frame: From enrollment to the report of surgical pathology,up to two weeks.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 17, 2017
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
January 11, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 11, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC-[2014]-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Raw audio files and corresponding metadata files for this study are uploaded and shared.
The underlying code for this study, including PRAAT scripts for speech preprocessing and automatic feature extraction, and python codes for speech omics representation, can be accessed.
IPD Sharing Time Frame
permanent valid
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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